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Status unknownNCT06043661Updated Sep 21, 2023

Early Detection of Breast Cancer

An observational study in Breast Neoplasms, sponsored by Datar Cancer Genetics Inc. Status unknown at 1 site in United States. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Datar Cancer Genetics Inc · Observational

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
40 Years and older
Sex
Female
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Study summary

The TriNetra™ Breast test is intended for use as a breast cancer screening test that evaluates Circulating Tumor Cells (CTCs) associated with breast cancer. The TriNetra™Breast test should be a useful breast cancer screening option for asymptomatic women 40 years of age and older.

This pivotal study is designed to provide evidence of test performance and to demonstrate its safety in the intended use population in the USA.

Read the detailed description

This prospective, case-cohort study evaluates the sensitivity and specificity of the TriNetra™-Breast test for breast cancer (adenocarcinoma) screening in women aged 40 years and older. Approximately 700 subjects will be enrolled in one of the two non-overlapping cohorts in this study. Cohort A will enroll about 500 subjects with a standard risk of breast cancer who fulfill the enrollment criteria. Cohort B will enroll approximately 200 subjects with a mammogram result of BI-RADS 4 or 5.

The results of TriNetra™ -Breast will be compared with the results of mammography. The corresponding diagnostic biopsy pathology results obtained as the standard of care will be correlated with test results to confirm the performance estimates (when indicated). Mammography will be the reference standard of evaluation of breast screening status for cohort A. Histopathology report will be the reference standard to evaluate the malignant or non-malignant clinical status for cohort B. Availability of histopathological results is mandatory for the evaluation of cohort B.

02

Conditions studied

  • Breast Neoplasms

Keywords

  • Early Detection
  • Mammography
  • Circulating Tumor Cells
  • Cancer Screening
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In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 700 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Datar Cancer Genetics Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population will consist of women aged 40 years and older. The target enrollment will be approximately 700 subjects, who will be divided into two non-overlapping cohorts.

All subjects enrolled in the study will undergo a blood draw for TriNetraTM Breast around the time of mammography. The blood draw will have to be performed no more than 60 days after the mammography and before the breast biopsy (Cohort B).

Eligibility criteria

Inclusion Criteria:

A). For Cohort A (500 subjects are targeted to enroll)

  1. No prior diagnosis of (any) cancer
  2. Women aged 40 years and above at the time of mammography
  3. Provision of signed informed consent
  4. Capable of providing adequate health history
  5. No co-morbidity which could impair study participation or sample collection
  6. Blood draw within sixty (60) days of performance of screening mammography
  7. A redacted/deidentified mammography report will be available and provided
  8. If any prior mammography was performed, the BI-RADS score should be 1 or 2 or 3
  9. Willingness to accept follow-up contact every 6 months for up to 2 years.
  10. Agreeable to share any future biopsy or imaging data for a maximum of 2 years from study blood draw.

B). For Cohort B (BI-RADS 4 and 5) (200 subjects are targeted to enroll)

  1. No prior diagnosis of (any) cancer
  2. Women aged 40 years and above at the time of mammography
  3. Provision of signed informed consent
  4. Current mammography indicating BI-RADS 4a,4b, 4c, or 5
  5. Capable of providing adequate health history
  6. No co-morbidity which could impair study participation or sample collection
  7. Blood draw within sixty (60) days of mammography and prior to biopsy of the breast
  8. Yet to undergo tissue diagnostic procedure for breast lesion such as fine needle, core, or excisional biopsy
  9. A redacted/deidentified mammography report and redacted/de-identified pathology report will be available and provided
  10. Willingness to accept follow-up contact every 6 months for up to 2 years.
  11. Agreeable to share any future repeat biopsy or imaging data for a maximum of 2 years from study blood draw.

C). Exclusion Criteria

  1. Prior diagnosis of (any) cancer
  2. Subjects who are receiving any investigational agent.
  3. Pregnant women are excluded from this study
  4. Breastfeeding women are excluded from this study
  5. Blood transfusion within 30 days prior to screening,
  6. Subject has any condition that in the opinion of the investigator should preclude participation in the study.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • BI-RADS score 1 or 2 or 3 (Cohort A)

    Subjects with a standard risk of breast cancer aged 40 years and above at the time of mammography with the BI-RADS score 1 or 2 or 3

  • BI-RADS score 4 or 5 (Cohort B)

    Subjects aged 40 years and above at the time of mammography with the BI-RADS score 4 or 5

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What researchers measure

Primary outcomes

  1. The primary endpoint of this study is the sensitivity and specificity of TriNetra Breast for breast cancer screening in women 40 years and older, using mammography and histopathology confirmed diagnosis (when relevant) as the reference methods.

    The study evaluates the clinical sensitivity and specificity of the TriNetra Breast in Mammography-Negative (BIRAD 1/2/3) and Mammography-Positive (BIRAD 4/5) Cohorts

    Time frame: 2 years

Secondary outcomes

  1. The Positive Predictive Values (PPV) and Negative Predictive Values (NPV)

    The study evaluates the PPV and NPV of the TriNetra Breast for breast cancer screening in women 40 years and older, using mammography and histopathology confirmed diagnosis (when relevant) as the reference methods.

    Time frame: 2 years

  2. Detection rates by TNM stage

    The study evaluates the detection rates (sensitivity in %) by TNM stage for the TriNetra Breast test, using surgical pathology evaluation as a reference.

    Time frame: 2 years

  3. Clinical performance in dense breast findings on mammography

    The study evaluates the clinical sensitivity and specificity (in %) for the TriNetra Breast test in dense breast findings on mammography

    Time frame: 2 years

  4. Sensitivity and specificity for ductal carcinoma in situ (DCIS) detection

    The study evaluates the clinical sensitivity and specificity (in %) for the TriNetra Breast test in ductal carcinoma in situ (DCIS) detection.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Rogel Cancer Center
    Ann Arbor, Michigan 48109, United States
    • Ulka Vaishampayan, MD · Contact · vaishamu@med.umich.edu · 734-936-7813
    • Stephanie K Patterson, MD FACR FSBI · Sub investigator
    • Wahida Rahman (Tania), MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Crook T, Leonard R, Mokbel K, Thompson A, Michell M, Page R, Vaid A, Mehrotra R, Ranade A, Limaye S, Patil D, Akolkar D, Datta V, Fulmali P, Apurwa S, Schuster S, Srinivasan A, Datar R. Accurate Screening for Early-Stage Breast Cancer by Detection and Profiling of Circulating Tumor Cells. Cancers (Basel). 2022 Jul 9;14(14):3341. doi: 10.3390/cancers14143341. PubMed 35884402 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Dec 2023, 10 months after the start.

Of 153 industry-sponsored observational studies under Breast Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 74. This study's planned 10 months is below that.

Counting every sponsor, half of 1,165 studies reached it within 58 months; a quarter within 26 and three quarters within 125.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2023
First posted
Sep 21, 2023
StartActual
Feb 9, 2023
Primary completionEst.
Dec 2023
CompletionEst.
Dec 2025
Last update
Sep 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06043661
Lead sponsor
Datar Cancer Genetics Inc
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Feb 9, 2023
Primary completion
Dec 2023 (estimated)
Completion
Dec 2025 (estimated)
Last update
Sep 21, 2023

Study contacts

Ulka Vaishampayan, MBBS,MD
Contact
vaishamu@umich.edu
+17349367813

Oversight

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

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