Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Biospecimen collection

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Sameek Roychowdhury, MD, PhD; Phone Number: 614-685-5842; Email: Sameek.Roychowdhury@osumc.edu
• Study Contact Backup: Name: Ohio State University Comprehensive Cancer Center; Phone Number: 1-800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Wexner Medical Center
      • Contact: Sameek Roychowdhury, MD, PhD; Phone Number: 614-685-5842; Email: Sameek.Roychowdhury@osumc.edu
      • Principal Investigator: Sameek Roychowdhury, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced or refractory cancer

Description

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants receiving new therapy based on study findings	Impact on clinical care	Up to 24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of days to return results	Determine average number of days for return of results	Up to 24 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Sameek Roychowdhury, MD, PhD, Ohio State University Wexner Medical Center

Publications and helpful links

General 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.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2013
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: March 7, 2014
• First Submitted That Met QC Criteria: March 14, 2014
• First Posted (Estimated): March 18, 2014

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cancer Genomics; Tumor Sequencing
• Other Study ID Numbers: OSU-13053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No