Kidney Cancer Clinical Trial

Drug Sensitivity and Mutation Profiling

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.

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Full 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

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Eligibility Criteria

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.

Study is for people with:

Kidney Cancer

Estimated Enrollment:

14

Study ID:

NCT04956198

Recruitment Status:

Completed

Sponsor:

Florida International University

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There is 1 Location for this study

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Nicklaus Children's Hospital
Miami Florida, 33155, United States

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Study is for people with:

Kidney Cancer

Estimated Enrollment:

14

Study ID:

NCT04956198

Recruitment Status:

Completed

Sponsor:


Florida International University

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