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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00632 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen collection | Other | Specimens to be collected include a fresh tumor biopsy, previously obtained tumor specimens or blocks (if available), whole blood, serum, plasma and buccal smear. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants receiving new therapy based on study findings | Impact on clinical care | Up to 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of days to return results | Determine average number of days for return of results | Up to 24 months |
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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:
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Patients with advanced or refractory cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Contact | 1-800-293-5066 | OSUCCCClinicaltrials@osumc.edu | |
| Sameek Roychowdhury, MD, PhD | Contact | 614-685-5842 | Sameek.Roychowdhury@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sameek Roychowdhury, MD, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31371345 | Derived | 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. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Tumor Biopsy Whole Blood Serum Buccal Smear Plasma Formalin Fixed Paraffin Embedded (FFPE) Tissue