Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Cancer Clinical Trial

Official title:

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02090530
• Other study ID #: OSU-13053
• Status: Recruiting
• Start date: November 4, 2013
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: Ohio State University Comprehensive Cancer Center
• Phone: 1-800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants receiving new therapy based on study findings	Impact on clinical care	Up to 24 Months
Secondary	Average number of days to return results	Determine average number of days for return of results	Up to 24 months

External Links

•   The Jamesline