Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing
- Conditions
- Cancer
- Registration Number
- NCT02090530
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
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A histologically or cytologically confirmed diagnosis of cancer
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Patients with any malignancy.
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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.
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Procedure-specific signed informed consent prior to initiation of any study-related procedures.
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Women and minorities are included in this protocol.
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Patients with multiple malignancies remain eligible.
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Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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
Related Research Topics
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Trial Locations
- Locations (1)
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Ohio State University Wexner Medical Center🇺🇸Columbus, Ohio, United StatesSameek Roychowdhury, MD, PhDPrincipal Investigator