Molecular Markers of Chemosensitivity for Bladder Cancer

• Conditions: Effects of Chemotherapy; Bladder Cancer
• Interventions: Other: Expression analysis

• Registration Number: NCT02074241
• Lead Sponsor: Southwest Hospital, China

Brief Summary

The purpose of this study is to try to figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.

Detailed Description

Figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.

Study Timeline

• Status Verified: 2014-02
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-27
• Last Update Submitted: 2014-02-27
• Study First Posted: 2014-02-28
• Last Update Posted: 2014-02-28
• Study Start: 2014-03
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
2. .Gone through standardize radical cystectomy and pelvic lymphadenectomy or inoperable.
3. Transitional cell carcinoma of bladder, stage pT3N0M0,T2N1M0-T3-4N1-2M1.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.
4. Electrocorticography(ECOG) performance status 0-2.
5. Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL,
6. Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase(SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x upper limit of normal (ULN).
7. Creatinine clearance rate,Ccr ≥ 60%
8. ECG：no arrhythmias, no myocardial infarction. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.

Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.

Exclusion Criteria

1. Past history of systemic chemotherapy
2. Serious heart and lung dysfunction.
3. Associated with central or peripheral neuropathy greater than 2 grade.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative Expression	Expression analysis	Expression analysis:Negative expression of DNA repair-related genes(XPC, XPF, Brca1, Rad51, SNF5,etc) in bladder cancer specimens.
Positive Expression	Expression analysis	Expression analysis:Positive expression of DNA repair-related genes(XPC, XPF, Brca1, Rad51,SNF5, etc) in bladder cancer specimens.

Primary Outcome Measures

Name	Time	Method
cancer progressive free survival rate	60 months

Secondary Outcome Measures

Name	Time	Method
overall survival	60 months

Trial Locations

Locations (1)

Southwest hospital,Chian; 🇨🇳 Chongqing, Chongqing, China