Drug Sensitivity and Mutation Profiling

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    15
  • sponsor
    Florida International University
Updated on 19 July 2021
tumor cells

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
Clinical Study IdentifierNCT04956198
SponsorFlorida International University
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged 21 years or younger at the time of enrollment on this study of any gender, race, or ethnicity
Subjects with suspected or confirmed diagnosis of all types of sarcomas
Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers)
Subjects are willing to have a blood draw or buccal swab done for the purposes of genetic testing
Subjects or their parents or legal guardians willing to sign informed consent
Subjects aged 7 to 17 willing to sign assent

Exclusion Criteria

Subjects who do not have malignant tissue available and accessible
The amount of excised malignant tissue is not sufficient for ex vivo drug testing and/or genetic profiling
Patients with other types of tumors and tumors that have a high (>90%) cure rate with safe standard therapy
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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