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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01206426

Enrollment

Registered

2010-09-21

Start date

2009-10-31

Completion date

2017-10-16

Last updated

2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Cancer

Keywords

Urothelial, cancer, cisplatin, neoadjuvant, chemotherapy, germline

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Genetic Determinants of pT0 Status	3 years	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

Measure	Time frame	Description
Molecular Determinants of pT0 Status	3 years	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.

Countries

United States

Outcome results