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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01206426
First received: September 13, 2010
Last updated: March 3, 2014
Last verified: March 2014
  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
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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206426

Contacts
Contact: Peter H O'Donnell, MD 773-702-7564 ext 27564 podonnel@medicine.bsd.uchicago.edu

Locations
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         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Peter H O'Donnell, MD University of Chicago
  More Information

No publications provided

Responsible Party: 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: March 3, 2014
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

ClinicalTrials.gov processed this record on September 22, 2014