Urothelial Cancer Clinical Trial
Official title:
Identification of Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer
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.
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.
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