Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

NCT02090530 | Recruiting

• 2 other identifiers: OSU-13053NCI-2014-00632
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Conditions

Cancer

Keywords

Cancer Genomics; Tumor Sequencing

Outcome Measures

Primary Outcomes (1)

• Number of participants receiving new therapy based on study findings

  Impact on clinical care

  Up to 24 Months

Secondary Outcomes (1)

• Average number of days to return results

  Up to 24 months

Study Arms (1)

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

Biospecimen collection OTHER

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

Advanced Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced or refractory cancer

You may qualify if:

• A histologically or cytologically confirmed diagnosis of cancer
• Patients with any malignancy.
• 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.
• Procedure-specific signed informed consent prior to initiation of any study-related procedures.
• Women and minorities are included in this protocol.
• Patients with multiple malignancies remain eligible.
• Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible.

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 31371345 DERIVED

Related Links

• The Jamesline

Biospecimen

Retention: SAMPLES WITH DNA

Tumor Biopsy Whole Blood Serum Buccal Smear Plasma Formalin Fixed Paraffin Embedded (FFPE) Tissue

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sameek Roychowdhury, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ohio State University Comprehensive Cancer Center

CONTACT

1-800-293-5066; OSUCCCClinicaltrials@osumc.edu

Sameek Roychowdhury, MD, PhD

CONTACT

614-685-5842; Sameek.Roychowdhury@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 18, 2014
• Study Start: November 4, 2013
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)