Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing
Study Details
Study Description
Brief Summary
Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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 Design
Arms and Interventions
Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Number of participants receiving new therapy based on study findings [Up to 24 Months]
Impact on clinical care
Secondary Outcome Measures
- Average number of days to return results [Up to 24 months]
Determine average number of days for return of results
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ohio State University Wexner Medical Center | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Ohio State University Comprehensive Cancer Center
Investigators
- Principal Investigator: Sameek Roychowdhury, MD, PhD, Ohio State University Wexner Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- OSU-13053