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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Identification of Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer|
- Genetic Determinants of pT0 Status [ Time Frame: 3 years ] [ Designated as safety issue: No ]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.
- Molecular Determinants of pT0 Status [ Time Frame: 3 years ] [ Designated as safety issue: No ]To perform companion genetic or molecular analyses of other previously‐identified gene, SNP, or microRNA "cisplatin susceptibility" candidates in these patients, using tumor or germline tissue.
Biospecimen Retention: Samples With DNA
Blood (germline) and tumor tissue samples will be used to perform genetic analysis. The purpose of this analysis is to determine whether a set of "cisplatin susceptibility" polymorphisms predict complete pathologic response to cisplatin-based chemotherapy and to identify novel determinants which may predict response to cisplatin-based chemotherapy.
Samples will be biobanked for future analysis of genetic determinants.
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206426
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Peter H O'Donnell, MD||University of Chicago|