Drug Sensitivity and Mutation Profiling
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- STATUS
- Recruiting
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- End date
- Dec 31, 2022
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- participants needed
- 15
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- sponsor
- Florida International University
Summary
This study is a prospective, non-randomized observational study. Freshly isolated tumor cells will be tested for chemosensitivity to the standard of care drugs as single agents and in combinations using state-of-the-art viability assay designed for ex-vivo high-throughput drug sensitivity testing (DST). In addition, the genetic profile of the tumor will be obtained from the medical records and correlated with drug response.
Description
The excised tumors or a biopsy will be interrogated for sensitivity or resistance to FDA-approved and/or available investigational agents. In addition, normal samples (blood or buccal swab) will be collected for genetic analysis of germline mutations and cancer predisposition markers. The timeframe between the sample acquisition and ex vivo DST results return will be approximately 5-10 working days. All drugs tested in the DST assay will be assigned a hybrid score reflecting the tumor's sensitivity and drug toxicity.
This is an observational study and not a treatment protocol. It will assess how ex vivo drug testing and mutation profiling may predict clinical outcomes (response, survival, or relapse). The treating physician will decide which of the standard treatment options is appropriate independent of the DST results. The results of DST will not be available to the treating physician at the time of decision on the treatment regimen. DST will include all drugs from the standard treatment regimens available for all types of sarcomas
Details
| Condition | Hereditary Neoplastic Syndrome, Soft Tissue Sarcoma, Ewing's sarcoma, Rhabdoid Tumor, Childhood Sarcoma of Soft Tissue, Sarcoma (Pediatric), Nephroblastoma, bone sarcoma, Rhabdomyosarcoma, Sarcoma, Malignant neoplasm of kidney, Wilms' Tumor, Renal Cancer, Hereditary Cancer Syndromes, Osteosarcoma, Kidney Cancer |
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| Clinical Study Identifier | NCT04956198 |
| Sponsor | Florida International University |
| Last Modified on | 19 July 2021 |
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