Identification of Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer
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
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
Observational Model: Case-Only, Time Perspective: Prospective
Genetic Determinants of pT0 Status
To perform genetic analysis of germline samples from these patients to determine whether a set of "cisplatin susceptibility" polymorphisms predict complete pathologic response to cisplatin‐based chemotherapy.
Peter H O'Donnell, MD
University of Chicago
United States: Institutional Review Board
|University of Chicago||Chicago, Illinois 60637|