Clinical trial NCT01206426: Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer
Official title: Identification of Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Cancer
Keywords: Urothelial, cancer, cisplatin, neoadjuvant, chemotherapy, germline
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients who are about to begin neoadjuvant cisplatin-based chemotherapy for urothelial cancer and who have consented to IRB approved protocols #15550B and/or TRIDOM (IRB #14104B).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Genetic Determinants of pT0 Status
timeFrame: 3 years
Secondary outcomes:
measure: Molecular Determinants of pT0 Status
timeFrame: 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Peter H O'Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References: