- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02074241
Molecular Markers of Chemosensitivity for Bladder Cancer
February 27, 2014 updated by: Zhiwen Chen, Southwest Hospital, China
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
The purpose of this study is to try to figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chongqing
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Chongqing, Chongqing, China, 400030
- Southwest hospital,Chian
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
- The patients of locally advanced, recurrent, metastatic transitional cell carcinoma.
- Gone through standardize radical cystectomy and pelvic lymphadenectomy or inoperable.
- Experienced adjuvant chemotherapy(Gemcitabine and Cisplatin).
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Analysis of the expression of DNA repair genes (XPC, XPF, Brca1, Rad51,SNF5, etc.) in bladder cancer specimens.
Other Names:
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Negative Expression
Expression analysis:Negative expression of DNA repair-related genes(XPC, XPF, Brca1, Rad51, SNF5,etc) in bladder cancer specimens.
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Analysis of the expression of DNA repair genes (XPC, XPF, Brca1, Rad51,SNF5, etc.) in bladder cancer specimens.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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cancer progressive free survival rate
Time Frame: 60 months
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60 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 60 months
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60 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zhiwen Chen, M.D,Ph.D, Southwest Hospital, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Anticipated)
April 1, 2019
Study Completion (Anticipated)
April 1, 2019
Study Registration Dates
First Submitted
February 26, 2014
First Submitted That Met QC Criteria
February 27, 2014
First Posted (Estimate)
February 28, 2014
Study Record Updates
Last Update Posted (Estimate)
February 28, 2014
Last Update Submitted That Met QC Criteria
February 27, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012XLC02-2
- 2012XLC02 (Other Grant/Funding Number: 2012XLC02,Third Military Medical University,China)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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