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RecruitingNCT03448926Updated Apr 17, 2026

The PREDICT Registry:

An observational study in DCIS, Stage 0 Breast Cancer and Ductal Breast Carcinoma In Situ, sponsored by PreludeDx. Recruiting at 30 sites in United States. Open to female participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by PreludeDx · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
3,000
Ages
30 Years to 85 Years
Sex
Female
01

Study summary

This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each participating institution.

Read the detailed description

After a diagnosis of DCIS, the most representative tissue block (or 10 sections mounted on charged slides cut at 3-4 microns) will be sent to PreludeDx for DCISionRT. The most representative specimen should be selected from tissue collected via direct tumor biopsy (either core needle or excisional biopsy) as part of routine patient care. Patients must be enrolled in the study and the enrollment and pre-testing data forms must be completed and submitted before the DCISionRT results are reported. Then, after review of the DCISionRT results, the investigators complete and submit the post-testing data form. The patient may then be followed for up to 10 years (or until death) with completion of 5- and 10-year follow-up forms.

All study data will be stored in an encrypted, HIPAA-compliant database maintained by the coordinating center. Each consented patient will be assigned a unique Study ID number. Study personnel at each institution will maintain an electronic key to link the Study IDs of its own patients to the patients' local medical record number. All personal health information (PHI) will remain at the local institution and only de-identified data will be uploaded to the national registry. No genetic test results that may be used to identify the patient will be included in the database.

This study is designed to assess the magnitude of and conditions impacting physician treatment recommendations based on the DCISionRT test results, assessing patient preference, and within various clinicopathologic subgroups. This will also be the largest prospective determination of IBR outcomes with DCISionRT test result correlates to date.

Part I of the PREDICT Registry recently completed enrollment of 2,500 subjects for whom DCISionRT results had been reported using the original test protocol that classified patients into two risk groups, Low Risk and Elevated Risk.64

Part II of the PREDICT Registry will enroll up to an additional 3,000 subjects from 15 to 30 sites within the United States with each site enrolling between 100 and 300 patients. DCISionRT results will be reported using the updated test protocol that classifies patients into three risk groups, Low Risk, Elevated Risk and Residual Risk. Part II study procedures will be conducted exactly the same as Part I, except that further patient demographics and treatment preference, treatment recommendation details, and patient upstaging will be collected. Additional questions will be asked to determine how physicians use the Residual Risk group classification to make treatment decisions. De-identified imaging data may also be collected, and de-identified patient tissue samples may be collected after 1 year.

02

Conditions studied

  • DCIS
  • Stage 0 Breast Cancer
  • Ductal Breast Carcinoma In Situ

Keywords

  • DCIS
  • molecular testing
  • risk of recurrence
  • treatment decision
  • decision impact
  • predictive
03

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will be selected from the clinical practices of the participating investigators and institutions. Patients who have been recently diagnosed with DCIS and are being evaluated for the need for further therapy will be screened for eligibility per the following eligibility criteria. Female patients 30 to 85 years with histologically confirmed ductal carcinoma in situ (DCIS) in a single breast of size less than 6 cm without evidence of invasive or microinvasive cancer and clinically eligible to receive breast-conserving surgery with or without radiation therapy.

Inclusion criteria

  1. Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).
  2. Patient must have the DCISionRT test ordered during routine patient care.
  3. Patient must be eligible for or have recently completed breast conserving surgery.
  4. Patient must be eligible to receive radiation and/or systemic treatment.
  5. Patient must be 30 to 85 years old.
  6. Patient must have tumor size of less than 6 cm.
  7. Patient must have been diagnosed with DCIS within 120 days of consent.

Exclusion criteria

Exclusion criteria

  1. Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
  2. Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.
  3. Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
  4. Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
  5. Patient has a prior history of in-field radiation in the ipsilateral breast.
  6. Patient has had prior systemic endocrine or chemotherapy prior to testing.
  7. Patient is pregnant.
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • DCIS

    Patients must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast without evidence of invasive cancer (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable)

    Other: Treatment recommendation surveys · Device: 7-gene biosignature

Interventions

  • OtherTreatment recommendation surveys

    Treatment Recommendation Surveys are completed by the treating physicians before and after receiving results from the DCISionRT test, which is prognostic for risk of recurrence over 10 years and predictive for benefit from radiation therapy.

  • Device7-gene biosignature

    Ordering the 7-gene biosignature assay (DCISionRT) as a part of routine care for DCIS is a prerequisite (inclusion criterion) for the study. The study is not designed to determine the efficacy of the assay, rather it is designed to meausre the impact of the assay results on treatment decisions for patients with DCIS.

05

What researchers measure

Primary outcomes

  1. Percent of Cases with Changes in Treatment Recommendation

    The percent of cases in which treatment recommendations are changed after the test DCISionRT test results become available. The study will collect details on physician treatment recommendations and patient preference before and after the availability of the molecular test (DCISionRT) results. The data elements include type of surgery (lumpectomy, therapeutic mastectomy, contralateral prophylactic mastectomy), type of radiation therapy (none, IORT, APBI/PBI, whole breast RT, boost) and endocrine therapy.

    Time frame: From enrollment to the beginning of treatment.

Secondary outcomes

  1. Function of Tumor Factors

    Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of tumor factors (tumor size, grade, architecture, necrosis, palpability, surgical margins, hormone receptor status).

    Time frame: 5 years

  2. Function of Tumor and Demographic Factors

    Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of tumor factors (tumor size, nuclear grade, architecture, necrosis, palpability, surgical margins, hormone receptor status). Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of demographic factors (age; ethnicity; family history, education, marital status, geographic region).

    Time frame: From enrollment to the beginning of treatment.

Other outcomes

  1. Distribution of DCISionRT scores across the cohort

    Each patient will receive the following results from the DCISionRT test: Decision Score (DS, 0.8-10.0), Residual Risk subtype (DS 9.2).

    Time frame: From enrollment to the beginning of treatment.

  2. Function of Geographic Region

    Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of the geographic region of the investigator, type of institution, or type of treating physician.

    Time frame: From enrollment to the beginning of treatment.

06

Study locations

30 of 30 sites recruiting
  • Arizona Center for Cancer Care
    Scottsdale, Arizona 85258, United States
    • Penny Labriola · Contact · penny.labriola@arizonaccc.com · 480-278-8261
    • Shakila Rajack, MBBS · Contact · shakila.rajack@arizonaccc.com · 480-278-8300
    • Justin Famoso, MD · Sub investigator
    • Jason Samuelian, DO · Sub investigator
    • Anushka Patel, MD · Principal investigator
    • Daniel Reed, DO · Sub investigator
    • Sommer Gunia, DO · Sub investigator
    • Scott Tannehill, MD · Sub investigator
    • Cory Heal, MD · Sub investigator
    • John Davis, MD · Sub investigator
    • Steven Sckolnik, MD · Sub investigator
    • Sara Zakem, MD · Sub investigator
    • Brenda Moorthy, DO · Principal investigator
    • Apar Gupta, MD · Sub investigator
    • Elizabeth Jeans, MD · Sub investigator
    • Rezwan Chowdhury, MD · Sub investigator
    • Kimberli Cox, MD · Sub investigator
    • Christi Bourne, MD · Sub investigator
    • Gerald Lucas, MD · Sub investigator
    • Christopher Biggs, MD · Sub investigator
    • Subhakar Mutyala, MD · Sub investigator
    • Ashley Dipasquale, MD · Sub investigator
    • Ashley Albert, MD · Sub investigator
    Recruiting
  • University of California San Diego
    La Jolla, California 92093, United States
    • Sauntee Braddock · Contact · sbraddock@health.ucsd.edu · 858-822-6040
    • Karen Tye, MD · Sub investigator
    • Cathryn Yashar, MD · Sub investigator
    • Chika Nwachukwu, MD PhD · Sub investigator
    • Dominique Rash, MD · Principal investigator
    • Sara Grossi, MD · Sub investigator
    • Gina Masny, MD · Sub investigator
    • Ava Armani, MD · Sub investigator
    • James Urbanic, MD · Sub investigator
    • Anne Wallace, MD · Sub investigator
    • Asona Lui, MD PhD · Sub investigator
    • Jyoti Mayadev, MD · Sub investigator
    • Sarah Blair, MD · Principal investigator
    • Julie Le, MD · Sub investigator
    Recruiting
  • Sutter Health
    San Mateo, California 94401, United States
    • Silvia Gonzalez · Contact · silvia.gonzalez3@sutterhealth.org · 650-696-4814
    • Daniel Schiffner, MD · Sub investigator
    • Al Taira, MD · Sub investigator
    • Dhara MacDermed, MD · Principal investigator
    • Amanda Wheeler, MD · Principal investigator
    • Anne Peled, MD · Sub investigator
    • Chris Neville, MD · Sub investigator
    • Roy Abendroth, MD · Sub investigator
    • Janice Ryu, MD · Sub investigator
    • Sharon Dutton, MD · Sub investigator
    • Patricia Seid, MD · Sub investigator
    • Charlotte Kubicky, MD · Sub investigator
    • Michael Zhang, MD · Sub investigator
    • Natalia Colocci, MD · Sub investigator
    • Jorge Garcia-Young, MD · Sub investigator
    • Vikram Jairam, MD · Sub investigator
    • Nitin Rohatgi, MD · Sub investigator
    Recruiting
  • University of Colorado Anschutz Medical Campus
    Aurora, Colorado 80045, United States
    • Chitra Pai-Kulyadi · Contact · chitra.paikulyadi@cuanschutz.edu · 857-919-8557
    • Nicole Christian, MD · Sub investigator
    • Christine Fisher, MD MPH · Sub investigator
    • Blair Murphy, MD · Sub investigator
    • Sarah Tevis, MD · Principal investigator
    • Tim Waxweiler, MD · Sub investigator
    • Rachel Rabinovitch, MD · Principal investigator
    • Rebekah Maymani, MD · Sub investigator
    Recruiting
  • Baptist MD Anderson Cancer Center
    Jacksonville, Florida 32207, United States
    • Austin Anderson · Contact · austin.anderson@bmcjax.com · 904-202-7501
    • Julie Greenwalt, MD · Sub investigator
    • Laila Samiian, MD · Principal investigator
    • Mona Janfaza, MD · Sub investigator
    • Mark Augspurger, MD · Sub investigator
    • Lillie Osteen, MD · Sub investigator
    • Karen Ching-Tismal, MD · Sub investigator
    • Cynthia Anderson, MD · Principal investigator
    • Neenad Shah, MD · Sub investigator
    • Cathryn Johnson, MD · Sub investigator
    Recruiting
  • BayCare Health System
    Tampa, Florida 33607, United States
    • Jessica Hupp · Contact · jessica.hupp@baycare.org · 813-356-7168
    • Negar Golesorkhi, MD · Sub investigator
    • Nitesh Paryani, MD · Principal investigator
    • Geraldine Jacobson, MD · Sub investigator
    • Ronica Nanda, MD · Sub investigator
    • Roberto Diaz, MD · Sub investigator
    • Paula Lundgren, MD · Sub investigator
    • Bansi Savla, MD · Sub investigator
    • Robert Gabordi, MD · Principal investigator
    Recruiting
  • University of South Florida
    Tampa, Florida 33613, United States
    • Gabriela Martinez · Contact · gmartinez4@usf.edu · 305-878-5045
    • Renee Veleva · Contact · veleva@usf.edu · 813-821-8034
    • Abigail Beard, MD · Principal investigator
    • Sarah Merkel, MD · Sub investigator
    Recruiting
  • Emory University Winship Cancer Institute
    Atlanta, Georgia 30322, United States
    • Carlos Aguilera Zenteno · Contact · carlos.e.aguilera.zenteno@emory.edu · 404-778-4982
    • Sandra Parker, NP-C · Sub investigator
    • Paige Estep, NP · Sub investigator
    • Heather Gatcombe, MD · Sub investigator
    • Ashish Patel, MD · Sub investigator
    • Kristin Ward, MD · Sub investigator
    • Reshma Jagsi, MD DPhil · Sub investigator
    • Rohini Bhatia, MD · Sub investigator
    • Toncred Styblo, MD · Sub investigator
    • Clara Farley, MD · Sub investigator
    • Cletus Arciero, MD · Sub investigator
    • Monica Rizzo, MD · Principal investigator
    • Suniah Ayub, MD · Sub investigator
    • Vishal Dhere, MD · Sub investigator
    • Sunil Dutta, MD · Sub investigator
    • Mylin Torres, MD · Sub investigator
    • Natalie Ridge, DO · Sub investigator
    • Jolinta Lin, MD · Sub investigator
    • Karen Godette, MD · Sub investigator
    Recruiting
  • Endeavor Health (Northshore)
    Evanston, Illinois 60201, United States
    • William McMichael · Contact · wmcmichael@northshore.org · 847-570-2393
    • Katherine Kopkash, MD · Sub investigator
    • Elizabeth Poli, MD · Sub investigator
    • Gary Schreiber, MD · Sub investigator
    • Thomas TJ Smith, MD · Sub investigator
    • Katharine Yao, MD · Principal investigator
    • Cecylia Mizera, MD · Sub investigator
    • Vathsala Raghavan, MD · Principal investigator
    • Catherine Pesce, MD · Sub investigator
    Recruiting
  • MedStar Health Research Institute
    Baltimore, Maryland 21237, United States
    • Amy Avergas · Contact · amy.m.avergas@medstar.net · 443-777-8876
    • Jennifer Son, MD · Sub investigator
    • Luther Ampey, MD · Sub investigator
    • Paul Fowler, MD · Sub investigator
    • Maen Farha, MD · Sub investigator
    • Patricia Wehner, MD · Principal investigator
    • Andrew Satinsky, MD · Sub investigator
    • Marc Boisvert, MD · Sub investigator
    • Atsuko Okabe, MD · Sub investigator
    • Daria Abolghasemi, DO · Sub investigator
    • Pamela Randolph-Jackson, MD · Sub investigator
    • Adedamola Omogbehin, MD · Sub investigator
    • Katherine Chen, MD · Principal investigator
    • Stephen Ronson, MD · Sub investigator
    • Kelly Orwat, MD · Sub investigator
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
    • Amanda Faust · Contact · amanda_faust@dfci.harvard.edu · 973-818-7077
    • Faina Nakhlis, MD · Sub investigator
    • Alexis Graham-Stephenson, MD · Sub investigator
    • Christopher Vetter, MD · Sub investigator
    • Christina Minami, MD · Sub investigator
    • Laura Dominici, MD · Sub investigator
    • Olga Kantor, MD · Sub investigator
    • Ron Shiloh, MD · Sub investigator
    • Rinaa Punglia, MD · Sub investigator
    • Suniti Nimbkar, MD · Sub investigator
    • Jennifer Bellon, MD · Principal investigator
    • Brigid Killelea, MD · Sub investigator
    • Thanh Barbie, MD · Sub investigator
    • Jennifer Pretz, MD · Sub investigator
    • Elizabeth Mittendorf, MD PhD · Principal investigator
    • Fallon Chipidza, MD · Sub investigator
    • Ko Park, MD · Sub investigator
    • Stephanie MacAusland, MD · Sub investigator
    • Yilin Cao, MD · Sub investigator
    • Daphna Spiegel, MD · Sub investigator
    • Laura Warren, MD · Sub investigator
    • Graham Boyd, MD · Sub investigator
    • Esther Rhei, MD · Sub investigator
    • Julia Wong, MD · Sub investigator
    Recruiting
  • Corewell Health William Beaumont University Center
    Royal Oak, Michigan 48073, United States
    • Lisa Bliss · Contact · lisa.bliss@corewellhealth.org · 248-551-5166
    • Sayee Kiran, MD · Sub investigator
    • Joshua Dilworth, MD PhD · Sub investigator
    • Sirisha Nandalur, MD · Sub investigator
    • Nayana Dekhne, MD · Principal investigator
    • Zakiya Shakir, MD · Sub investigator
    Recruiting
  • Comprehensive Breast Care
    Troy, Michigan 48098, United States
    • Sevasti Vergis, DO · Contact · sevasti.vergis@corewellhealth.org · 224-636-0898
    • Rick Brown, MD · Principal investigator
    • Frank Vicini, MD · Principal investigator
    • Vito Antonucci, MD · Sub investigator
    • Ashley Richardson, DO · Sub investigator
    • Linsey Gold, DO · Sub investigator
    • Anita Antoniolli, MD · Sub investigator
    • Elizabeth Ekkel-Ayoub, DO · Sub investigator
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    • Mary Pecoraro, RN BSN · Contact · mpecoraro@wustl.edu · 314-273-0884
    • Rebecca Aft, MD PhD · Sub investigator
    • Julie Margenthaler, MD · Principal investigator
    • Imran Zoberi, MD · Principal investigator
    • Katherine Glover-Collins, MD PhD · Sub investigator
    • Maria Thomas, MD PhD · Sub investigator
    • Carmen Bergom, MD PhD · Sub investigator
    • William Gillanders, MD · Sub investigator
    Recruiting
  • Maimonides Cancer Center
    Brooklyn, New York 11220, United States
    • Vijaya Natarajan · Contact · vnatarajan@maimo.org · 718-765-2611
    • Joshua Feinberg, MD · Sub investigator
    • Jonathan Klein, MD · Sub investigator
    • Charusheela Andaz, MD · Sub investigator
    • Patrick Borgen, MD · Principal investigator
    • David Berlach, MD · Sub investigator
    • Catherine Chappuis, MD · Sub investigator
    Recruiting
  • Northwell Health Center for Advanced Medicine
    Lake Success, New York 11042, United States
    • Olivia Casareno · Contact · ocasareno@northwell.edu · 516-321-2200
    • Brianna Jones, MD · Principal investigator
    • Wesley Talcott, MD · Sub investigator
    • Paul Baron, MD · Principal investigator
    • Lucille Lee, MD · Sub investigator
    • Ashwatha Narayana, MD · Sub investigator
    • Beatrice Bloom, MD · Sub investigator
    • Ranjana Chaterji, DO · Sub investigator
    • Leila Tchelebi, MD · Sub investigator
    • Heather Zinkin, MD · Sub investigator
    • Clary Evans, MD · Sub investigator
    • Janna Andrews, MD · Sub investigator
    • Pond Kelemen, MD · Sub investigator
    Recruiting
  • NYU - Long Island
    Mineola, New York 11501, United States
    • Nadia Chowdhury · Contact · nadia.chowdhury@nyulangone.org · 347-327-4988
    • Jonathan Haas, MD · Sub investigator
    • Zhanna Logman, MD · Principal investigator
    • Amy Solan, MD · Sub investigator
    • Helen Pass, MD · Sub investigator
    • Sooojin Ahn, MD · Sub investigator
    Recruiting
  • NYU - Manhattan
    New York, New York 10016, United States
    • Nadia Chowdhury · Contact · nadia.chowdhury@nyulangone.org · 347-327-4988
    • Freya Schnabel, MD · Principal investigator
    • Mary Gemignani, MD · Sub investigator
    • Deborah Axelrod, MD · Sub investigator
    • Olivier Maisonet, NP · Sub investigator
    • Naamit Gerber, MD · Principal investigator
    • Camille Hardy-Abeloos, MD · Sub investigator
    • Oren Cahlon, MD · Sub investigator
    • Yuliya Sundatova, NP · Sub investigator
    • Amber Guth, MD · Sub investigator
    Recruiting
  • Columbia University Medical Center
    New York, New York 10032, United States
    • Christina Chesnakov · Contact · cc4047@cumc.columbia.edu · 646-317-4244
    • Zahra Ghiassi-Nejad, MD PhD · Sub investigator
    • Julie Choi, MD · Sub investigator
    • Arith Reyes, MD · Principal investigator
    • Eileen Connolly, MD PhD · Principal investigator
    • Bret Taback, MD · Sub investigator
    • Leah Katz, MD · Sub investigator
    • Roshni Rao, MD · Sub investigator
    • Lisa Wiechmann, MD · Sub investigator
    • Kristine Kim, MD · Sub investigator
    • Luona Sun, MD · Sub investigator
    • Lawrence Koutcher, MD · Sub investigator
    • Albert Lee, MD · Sub investigator
    Recruiting
  • Cleveland Clinic Akron General
    Akron, Ohio 44302, United States
    • Wendy Catchpole · Contact · catchpw@ccf.org · 330-344-6348
    • Amanda Mendiola, MD · Sub investigator
    • Ashok Ramalingam, MD · Sub investigator
    • Susan Hong, MD · Principal investigator
    • Praveen Pendyala, MD · Sub investigator
    • Salem Alfaifi, MD · Sub investigator
    • Mary Murray, MD · Sub investigator
    • Sarah Grabowski, MD · Sub investigator
    • Andrew Fenton, MD · Principal investigator
    Recruiting
  • Cleveland Clinic Foundation-Taussig Cancer Inst
    Cleveland, Ohio 44195, United States
    • Laura Luxenberg · Contact · luxenbl@ccf.org · 216-445-5256
    • Anna Chichura, MD · Sub investigator
    • Andrew Vassil, MD · Sub investigator
    • Henry Blair, MD · Sub investigator
    • Debra Pratt, MD · Sub investigator
    • Julie Lang, MD · Sub investigator
    • Ashok Ramalingam, MD · Sub investigator
    • Anthony Mastroianni, MD JD · Sub investigator
    • Praveen Pendyala, MD · Principal investigator
    • Betty Obi, MD · Sub investigator
    • Vincent Wu, MD · Sub investigator
    • Paula Escobar, MD · Sub investigator
    • Sarah Grabowski, MD · Sub investigator
    • Susan Hong, MD · Sub investigator
    • Lauren Kopicky, DO · Sub investigator
    • Stephanie Valente, DO · Sub investigator
    • Joycelin Canavan, MD · Sub investigator
    • Michael Weller, MD · Sub investigator
    • Zahraa AlHilli, MD · Sub investigator
    Recruiting
  • The Ohio State University
    Columbus, Ohio 43212, United States
    • Jean Koutou · Contact · jeanmartial.koutouessan@osumc.edu · 614-293-5637
    • William Carson, MD · Sub investigator
    • Doreen Agnese, MD · Principal investigator
    • Samilia Obeng-Gyasi, MD MPH · Sub investigator
    • Therese Andraos, MD · Sub investigator
    • Sachin Jhawar, MD · Sub investigator
    • Jacob Eckstein, MD · Sub investigator
    • Rebekah Young, MD · Sub investigator
    • Valerie Grignol, MD · Sub investigator
    • Sasha Beyer, MD PhD · Sub investigator
    Recruiting
  • Compass Oncology
    Tigard, Oregon 97223, United States
    • Aidan Walker · Contact · aidan.walker@compassoncology.com · 971-708-7600
    • Kiri Cook, MD · Sub investigator
    • Scott Schneider, MD · Sub investigator
    • John Schuler, MD · Sub investigator
    • Tris Arscott, MD · Principal investigator
    • Kati Dunham, MD · Sub investigator
    • Tammy De La Melena, MD · Principal investigator
    Recruiting
  • St Luke's University Health Network
    Easton, Pennsylvania 18045, United States
    • Helen McGunngle · Contact · helen.mcgunnigle@sluhn.org · 484-503-4600
    • Ahmad Rahman, MD · Sub investigator
    • Nicholas Cardiges, MD · Sub investigator
    • Bhartesh Shah, MD · Sub investigator
    • Benjamin Foster, MD · Sub investigator
    • Cassandra Cardarelli, MD · Sub investigator
    • David Andolino, MD · Sub investigator
    • Grace Fan, MD · Sub investigator
    • Tricia Kelly, MD · Principal investigator
    • Eleanor Harris, MD · Principal investigator
    • William Smith, MD · Sub investigator
    Recruiting
  • Sidney Kimmel Comprehensive Cancer Ctr - Jefferson
    Philadelphia, Pennsylvania 19027, United States
    • Jennifer Greene · Contact · jennifer.greene2@jefferson.edu · 215-600-7258
    • Scott Herbert, MD · Principal investigator
    • Stefania Nolano, DO · Principal investigator
    • Nicole Simone, MD · Sub investigator
    • Kristin Brill, MD · Sub investigator
    • Seye Adekeye, MD PhD · Sub investigator
    • Susanna Nazarian, MD PhD · Sub investigator
    • Pramila Anne, MD · Sub investigator
    Recruiting
  • AHN Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
    • Sarah Bailey-Hockin · Contact · sarah.bailey-hockin@ahn.org · 412-359-3826
    • Ryan VanDenBerg, MD · Sub investigator
    • Gunj Patel, MD · Sub investigator
    • Jennifer Saldanha, MD · Sub investigator
    • Talal Khan, MD · Sub investigator
    • Adam Johnson, MD · Sub investigator
    • Rubal Sharma, MD · Sub investigator
    • Mark Gannon, MD · Sub investigator
    • Bindu Rusia, MD · Principal investigator
    • Paul Renz, DO · Sub investigator
    • Basem Dahshan, MD · Sub investigator
    • Athanasios Colonias, MD · Sub investigator
    • Saleha Rizwan, MD · Sub investigator
    • Conrad Stachelek, MD PhD · Sub investigator
    • James Betler, DO · Sub investigator
    • Emil Fernando, MD · Sub investigator
    • Mary Freyvogel-Ramirez, MD · Sub investigator
    • Colin Champ, MD · Sub investigator
    • Amanda Deliere, MD · Sub investigator
    • Suzanna Coopey, MD · Principal investigator
    • Pritam Tayshetye, MD · Sub investigator
    Recruiting
  • Nashville Breast Center
    Nashville, Tennessee 37203, United States
    Recruiting
  • UT Southwestern Medical Center
    Dallas, Texas 75235, United States
    • Sarah Neufeld · Contact · sarah.hardee@utsouthwestern.edu · 214-645-8525
    • Rachel Wooldridge, MD · Sub investigator
    • Anvy Nguyen, MD · Sub investigator
    • Dillon Li, MD · Sub investigator
    • Mona Arbab, MD · Principal investigator
    • Stephanie Serres, MD PhD · Sub investigator
    • Deborah Farr, MD · Principal investigator
    • Maureen Aliru, MD PhD · Sub investigator
    • Anthony Froix, MD · Sub investigator
    • Asal Rahimi, MD · Sub investigator
    • Narine Wandrey, MD · Sub investigator
    • Prasanna Alluri, MD PhD · Sub investigator
    • Shruti Zaveri, MD · Sub investigator
    • Marilyn Leitch, MD · Sub investigator
    Recruiting
  • Baylor College of Medicine
    Houston, Texas 77030, United States
    • Ivan Marin · Contact · ivan.marin@bcm.edu · 713 798-3432
    • Shelly Sharma, MD · Principal investigator
    • Snehal Desai, MD · Sub investigator
    • Stacey Carter, MD · Sub investigator
    • Eric Silberfein, MD · Sub investigator
    • Alastair Thompson, MD · Sub investigator
    • Elizabeth Bonefas, MD · Principal investigator
    • Daniel Hamstra, MD PhD · Sub investigator
    • Christina Chapman, MD · Sub investigator
    • Krystal Morales Rivera, MD PhD · Sub investigator
    • Cary Hsu, MD · Sub investigator
    Recruiting
  • Texas Oncology
    Plano, Texas 75093, United States
    • Leah Plato · Contact · leah.plato@usoncology.com · 469-361-1905
    • Lynn Canavan, MD · Principal investigator
    • James Petrikas, DO · Principal investigator
    Recruiting
07

References and documents

Publications

  • Vicini F, Shah C, Mittal K, Weinmann S, Leo M, Mann GB, Warnberg F, Rabinovitch R, Czerniecki B, Meattini I, Khan AJ, Jhawar S, Gerber N, Willey SC, Borgen P, AlHilli Z, Kruse M, Dabbs D, Shivers SC, Daily A, Whitworth P, Alvarado M, Mouabbi JA, Moran M, Rugo H, O'Shaughnessy JA, Bremer T. Limitations in the Application of Clinicopathologic Factors Alone in Predicting Radiation Benefit for Women With Low-Risk Ductal Carcinoma In Situ After Breast Conserving Surgery: The Impact of a 7-Gene Biosignature Based on 10-Year Ipsilateral Breast Recurrence Rates. Int J Radiat Oncol Biol Phys. 2025 Nov 15;123(4):1090-1101. doi: 10.1016/j.ijrobp.2025.07.1411. Epub 2025 Jul 18. PubMed 40685017 ↗
  • Warnberg F, Karlsson P, Holmberg E, Sandelin K, Whitworth PW, Savala J, Barry T, Leesman G, Linke SP, Shivers SC, Vicini F, Shah C, Weinmann S, Mann GB, Bremer T. Prognostic Risk Assessment and Prediction of Radiotherapy Benefit for Women with Ductal Carcinoma In Situ (DCIS) of the Breast, in a Randomized Clinical Trial (SweDCIS). Cancers (Basel). 2021 Dec 3;13(23):6103. doi: 10.3390/cancers13236103. PubMed 34885211 ↗
  • Vicini FA, Mann GB, Shah C, Weinmann S, Leo MC, Whitworth P, Rabinovitch R, Torres MA, Margenthaler JA, Dabbs D, Savala J, Shivers SC, Mittal K, Warnberg F, Bremer T. A Novel Biosignature Identifies Patients With DCIS With High Risk of Local Recurrence After Breast Conserving Surgery and Radiation Therapy. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):93-102. doi: 10.1016/j.ijrobp.2022.06.072. Epub 2022 Sep 15. PubMed 36115740 ↗
  • Dabbs D, Mittal K, Heineman S, Whitworth P, Shah C, Savala J, Shivers SC, Bremer T. Analytical validation of the 7-gene biosignature for prediction of recurrence risk and radiation therapy benefit for breast ductal carcinoma in situ. Front Oncol. 2023 May 19;13:1069059. doi: 10.3389/fonc.2023.1069059. eCollection 2023. PubMed 37274253 ↗
  • Shah C, Bremer T, Cox C, Whitworth P, Patel R, Patel A, Brown E, Gold L, Rock D, Riley L, Kesslering C, Brown S, Gabordi R, Pellicane J, Rabinovich R, Khan S, Templeton S, Majithia L, Willey SC, Warnberg F, Gerber NK, Shivers S, Vicini FA. Correction to: The Clinical Utility of DCISionRT(R) on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery. Ann Surg Oncol. 2021 Dec;28(Suppl 3):878. doi: 10.1245/s10434-021-10138-3. No abstract available. PubMed 33997922 ↗
  • Shah C, Whitworth P, Vicini FA, Narod S, Gerber N, Jhawar SR, King TA, Mittendorf EA, Willey SC, Rabinovich R, Gold L, Brown E, Patel A, Vargo J, Barry PN, Rock D, Friedman N, Bedi G, Templeton S, Brown S, Gabordi R, Riley L, Lee L, Baron P, Majithia L, Mirabeau-Beale KL, Reid VJ, Hirsch A, Hwang C, Pellicane J, Maganini R, Khan S, MacDermed DM, Small W, Mittal K, Borgen P, Cox C, Shivers SC, Bremer T. The Clinical Utility of a 7-Gene Biosignature on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery: An Updated Analysis of the DCISionRT(R) PREDICT Study. Ann Surg Oncol. 2024 Sep;31(9):5919-5928. doi: 10.1245/s10434-024-15566-5. Epub 2024 Jun 25. PubMed 38916700 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03448926
Lead sponsor
PreludeDx
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Feb 27, 2018
Primary completion
Dec 2026 (estimated)
Completion
Dec 2036 (estimated)
Last update
Apr 17, 2026

Study contacts

Steven C Shivers, PhD
Contact
sshivers@preludedx.com
813-215-1749
Leona Hamrick, DHSc
Contact
lhamrick@preludedx.com
727-244-6411
Troy Bremer, PhD
principal investigator · PreludeDx
Pat W Whitworth, MD
study chair · PreludeDx
Rachel Rabinovitch, MD
study chair · University of Colorado, Denver
Pat Borgen, MD
study chair · Maimonides Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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