Cancer
Conditions
Keywords
Cancer Genomics, Tumor Sequencing
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 or therapies. This study includes a registry for longitudinal evaluation of patients whose cancer has FGFR mutations such as cholangiocarcinoma, pancreatic cancer, and others (telehealth).
Interventions
OTHERBiospecimen 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.
Sponsors
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants receiving new therapy based on study findings | Up to 24 Months | Impact on clinical care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average number of days to return results | Up to 24 months | Determine average number of days for return of results |
Countries
United States
Contacts
CONTACTOhio State University Comprehensive Cancer Center
CONTACTSameek Roychowdhury, MD, PhD
PRINCIPAL_INVESTIGATORSameek Roychowdhury, MD, PhD
Ohio State University
Outcome results
None listed