Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Recruiting

• Conditions: Cancer
• Interventions: Other: Biospecimen collection

• Registration Number: NCT02090530
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

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 Timeline

• Study Start: 2013-11-04
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced Cancer Patients	Biospecimen collection	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.

Primary Outcome Measures

Name	Time	Method
Number of participants receiving new therapy based on study findings	Up to 24 Months	Impact on clinical care

Secondary Outcome Measures

Name	Time	Method
Average number of days to return results	Up to 24 months	Determine average number of days for return of results

Trial Locations

Locations (1)

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States