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Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer

This study is currently recruiting participants.
Verified August 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Peter O' Donnell, University of Chicago
ClinicalTrials.gov Identifier:
NCT01206426
First received: September 13, 2010
Last updated: August 13, 2012
Last verified: August 2012
History of Changes

September 13, 2010
August 13, 2012
October 2009
August 2013   (final data collection date for primary outcome measure)
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.
Primary Study Objective [ 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.
Complete list of historical versions of study NCT01206426 on ClinicalTrials.gov Archive Site
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.
Secondary Study Objective [ 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.
Not Provided
Not Provided
 
Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer
Identification of 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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.
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).
Urothelial Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 89 Years
No
Contact: Peter H O'Donnell, MD 773-702-7564 ext 27564 podonnel@medicine.bsd.uchicago.edu
United States
 
NCT01206426
09-288-B
Yes
Peter O' Donnell, University of Chicago
University of Chicago
Not Provided
Principal Investigator: Peter H O'Donnell, MD University of Chicago
University of Chicago
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP