Identification of Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer
18 Years
89 Years
Both
Urothelial Cancer
Trial Information
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
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.
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.
Exclusion Criteria:
- Patients receiving cisplatin‐based chemotherapy for urothelial cancer in the adjuvant
setting or for metastatic disease.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Genetic Determinants of pT0 Status
Outcome Description:
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.
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Peter H O'Donnell, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Chicago
Authority:
United States: Institutional Review Board
Study ID:
09-288-B
NCT ID:
NCT01206426
Start Date:
October 2009
Completion Date:
December 2013
Related Keywords:
- Urothelial Cancer
- Urothelial, cancer, cisplatin, neoadjuvant, chemotherapy, germline
Name | Location |
|---|---|
| University of Chicago | Chicago, Illinois 60637 |
