Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2017-10-16

Brief Summary

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This is observational clinical trial to study adult urothelial cancer patients treated with cisplatin-based neoadjuvant chemotherapy.

Hypothesis: Identification of genetic and molecular "cisplatin susceptibility" biomarkers will allow identification of urothelial cancer patients most likely to benefit from cisplatin-based neoadjuvant chemotherapy.

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Detailed Description

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In this trial patients will submit germline (blood) and tumor tissue samples as part of two existing sample collection protocols for analysis of genetic and molecular markers governing response to chemotherapy. Pathologic review of tissue samples after neoadjuvant therapy will allow determination of the complete response rate (pT0 rate) and this will be compared between patients with "susceptible" and "resistant" genetic/molecular cisplatin susceptibility variants.

Primary Endpoint: Analysis of whether a small set of previously-identified germline "cisplatin susceptibility" polymorphisms associate with achievement of a complete pathologic response to neoadjuvant cisplatin-based chemotherapy in urothelial cancer patients.

Secondary Endpoints: To perform companion genetic or molecular analyses of other previously-identified gene, SNP, or microRNA "cisplatin susceptibility" candidates in these patients, using tumor and/or germline tissue.

Exploratory Endpoints: To perform unbiased, hypothesis-generating SNP, gene, or microRNA array studies to identify novel germline or tumor determinants which may predict response to cisplatin-based chemotherapy.

Conditions

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Urothelial Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with clinical T2 through T4 urothelial carcinoma of the bladder or upper tract.
* Patients must be deemed appropriate by the treating physician to require cisplatin-based neoadjuvant chemotherapy for urothelial cancer. Consideration of regional nodal status as part of the decision for appropriateness for neoadjuvant chemotherapy will be left to the treating physician.
* Patients must be scheduled to proceed to definitive urothelial cancer surgery, including either cystectomy or nephrectomy/ureterectomy, after chemotherapy.
* Age \>18 years.