Molecular Markers of Chemosensitivity for Bladder Cancer

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02074241

Enrollment

200

Registered

2014-02-28

Start date

2014-03-31

Completion date

2019-04-30

Last updated

2014-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Effects of Chemotherapy

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.

Interventions

OTHERExpression analysis

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
cancer progressive free survival rate	60 months

Secondary

Measure	Time frame
overall survival	60 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026