Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer
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Purpose
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 |
|---|
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Urothelial Cancer |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (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.
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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).
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.
Contacts and Locations| Contact: Peter H O'Donnell, MD | 773-702-7564 ext 27564 | podonnel@medicine.bsd.uchicago.edu |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Alicia Wyche, MAT 773-702-4271 ext 24271 awyche@uchicago.edu | |
| Principal Investigator: Peter H O'Donnell, MD | |
| Principal Investigator: | Peter H O'Donnell, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Peter O' Donnell, Instructor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01206426 History of Changes |
| Other Study ID Numbers: | 09-288-B |
| Study First Received: | September 13, 2010 |
| Last Updated: | August 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Urothelial, cancer, cisplatin, neoadjuvant, chemotherapy, germline |
Additional relevant MeSH terms:
|
Cisplatin Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013