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RecruitingNCT02090530Updated Apr 8, 2026

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

An observational study in Cancer, sponsored by Ohio State University Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Ohio State University Comprehensive Cancer Center · Observational

From the registry’s dates

  • Started Nov 2013; still recruiting 12 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study summary

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Read the detailed description

This study supports the collection of tumor specimens for CLIA-certified genomic testing and research testing in parallel. CLIA-certified tests have established measurements of accuracy and precision which allow for return of results. This study does not involve treatment, only testing, which could be used to meet eligibility criteria in other trials or therapies. This study includes a registry for longitudinal evaluation of patients whose cancer has FGFR mutations such as cholangiocarcinoma, pancreatic cancer, and others (telehealth).

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Conditions studied

  • Cancer

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Keywords

  • Cancer Genomics
  • Tumor Sequencing
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with advanced or refractory cancer

Inclusion criteria

  1. A histologically or cytologically confirmed diagnosis of cancer
  2. Patients with any malignancy.
  3. Patients must have tumor suitable for research tumor biopsy (as assessed by trained specialists in interventional radiology) and Patients are medically fit to undergo a tissue biopsy or surgical procedure to get tumor tissue OR If Patients do not have a tumor suitable for biopsy but have another tissue available for molecular evaluation.

    OR Patients are undergoing standard of care surgeries or procedures where fresh specimens will be first used for routine pathologic assessment and only then will leftover tissue be used for research purposes.

  4. Procedure-specific signed informed consent prior to initiation of any study-related procedures.
  5. Women and minorities are included in this protocol.
  6. Patients with multiple malignancies remain eligible.
  7. Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible.

Exclusion criteria

Exclusion Criteria:

  1. It is the enrolling study physicians discretion to decide if a patient is not fit enough to undergo tissue biopsy.
  2. Patients who are incarcerated are not eligible to participate.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Advanced Cancer Patients

    Individuals with advanced or refractory cancer must be identified by study personnel or their treating physician, deemed eligible for this study, and voluntarily agree to be enrolled in this protocol through an informed consent. Biospecimen collection includes a fresh tumor biopsy, previously obtained tumor specimens or blocks (if available), whole blood, serum, plasma and buccal smear.

    Other: Biospecimen collection

Interventions

  • OtherBiospecimen collection

    Specimens to be collected include a fresh tumor biopsy, previously obtained tumor specimens or blocks (if available), whole blood, serum, plasma and buccal smear.

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What researchers measure

Primary outcomes

  1. Number of participants receiving new therapy based on study findings

    Impact on clinical care

    Time frame: Up to 24 Months

Secondary outcomes

  1. Average number of days to return results

    Determine average number of days for return of results

    Time frame: Up to 24 months

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Study locations

1 of 1 sites recruiting
  • Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
    Recruiting
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References and documents

Publications

  • Krook MA, Bonneville R, Chen HZ, Reeser JW, Wing MR, Martin DM, Smith AM, Dao T, Samorodnitsky E, Paruchuri A, Miya J, Baker KR, Yu L, Timmers C, Dittmar K, Freud AG, Allenby P, Roychowdhury S. Tumor heterogeneity and acquired drug resistance in FGFR2-fusion-positive cholangiocarcinoma through rapid research autopsy. Cold Spring Harb Mol Case Stud. 2019 Aug 1;5(4):a004002. doi: 10.1101/mcs.a004002. Print 2019 Aug. PubMed 31371345 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, 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
NCT02090530
Lead sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sameek Roychowdhury (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Principal investigator
First posted
Mar 18, 2014
Start date
Nov 4, 2013
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 8, 2026

Study contacts

Ohio State University Comprehensive Cancer Center
Contact
OSUCCCClinicaltrials@osumc.edu
1-800-293-5066
Sameek Roychowdhury, MD, PhD
Contact
Sameek.Roychowdhury@osumc.edu
614-685-5842
Sameek Roychowdhury, MD, PhD
principal investigator · Ohio State University

Oversight

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

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