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Molecular Markers of Chemosensitivity for Bladder Cancer

NCT ID: NCT02074241

Last Updated: 2014-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-04-30

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.

Conditions

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Bladder Cancer Effects of Chemotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Positive Expression

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

Expression analysis

Intervention Type OTHER

Analysis of the expression of DNA repair genes (XPC, XPF, Brca1, Rad51,SNF5, etc.) in bladder cancer specimens.

Negative Expression

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

Expression analysis

Intervention Type OTHER

Analysis of the expression of DNA repair genes (XPC, XPF, Brca1, Rad51,SNF5, etc.) in bladder cancer specimens.

Interventions

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Expression analysis

Analysis of the expression of DNA repair genes (XPC, XPF, Brca1, Rad51,SNF5, etc.) in bladder cancer specimens.

Intervention Type OTHER

Other Intervention Names

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E-A

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Zhiwen Chen

M.D,Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiwen Chen, M.D,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, China

Locations

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Southwest hospital,Chian

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2012XLC02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012XLC02-2

Identifier Type: -

Identifier Source: org_study_id