Molecular Markers of Chemosensitivity for Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02074241
• Other study ID #: 2012XLC02-2
• Secondary ID: 2012XLC02
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 26, 2014
• Last updated: February 27, 2014
• Start date: March 2014
• Est. completion date: April 2019

Study information

• Verified date: February 2014
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Cancer
• Effects of Chemotherapy
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Southwest hospital,Chian	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cancer progressive free survival rate		60 months	Yes
Secondary	overall survival		60 months	Yes