Clinical trial NCT02090530: Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing
Official title: Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Cancer Genomics
Tumor Sequencing
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced or refractory cancer

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants receiving new therapy based on study findings
timeFrame: Up to 24 Months
Secondary outcomes:
measure: Average number of days to return results
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Sameek Roychowdhury, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krook MA, Bonneville R, Chen HZ, Reeser JW, Wing MR, Martin DM, Smith AM, Dao T, Samorodnitsky E, Paruchuri A, Miya J, Baker KR, Yu L, Timmers C, Dittmar K, Freud AG, Allenby P, Roychowdhury S. Tumor heterogeneity and acquired drug resistance in FGFR2-fusion-positive cholangiocarcinoma through rapid research autopsy. Cold Spring Harb Mol Case Stud. 2019 Aug 1;5(4):a004002. doi: 10.1101/mcs.a004002. Print 2019 Aug.