Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer
|ClinicalTrials.gov Identifier: NCT01206426|
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : May 4, 2018
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||79 participants|
|Official Title:||Identification of Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer|
|Actual Study Start Date :||October 2009|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||October 16, 2017|
- Genetic Determinants of pT0 Status [ Time Frame: 3 years ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206426
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Peter H O'Donnell, MD||University of Chicago|