Molecular Markers of Chemosensitivity for Bladder Cancer

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

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

Official Title
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Molecular Markers of Chemosensitivity for Locally Advanced, Recurrent and Metastatic Bladder Cancer Based on the Adjuvant Chemotherapy of Gemcitabine and Cisplatin-a Prospective Control Study

Conditions
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Bladder Cancer, Effects of Chemotherapy

Intervention / Treatment
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* Other: Expression analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months. .Gone through standardize radical cystectomy and pelvic lymphadenectomy or inoperable. 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. Electrocorticography(ECOG) performance status 0-2. Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL, 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). Creatinine clearance rate,Ccr ≥ 60% 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: Past history of systemic chemotherapy Serious heart and lung dysfunction. Associated with central or peripheral neuropathy greater than 2 grade.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive Expression<br>Expression analysis:Positive expression of DNA repair-related genes(XPC, XPF, Brca1, Rad51,SNF5, etc) in bladder cancer specimens. | Other: Expression analysis<br>* Analysis of the expression of DNA repair genes (XPC, XPF, Brca1, Rad51,SNF5, etc.) in bladder cancer specimens.<br>* Other names: E-A;|
| Negative Expression<br>Expression analysis:Negative expression of DNA repair-related genes(XPC, XPF, Brca1, Rad51, SNF5,etc) in bladder cancer specimens. | Other: Expression analysis<br>* Analysis of the expression of DNA repair genes (XPC, XPF, Brca1, Rad51,SNF5, etc.) in bladder cancer specimens.<br>* Other names: E-A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cancer progressive free survival rate |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 60 months |