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Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Approved-not yet active 18 and over Other GE-196-001 NCT00785694

Trial Description

Summary

This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).

Eligibility Criteria

Inclusion Criteria:

• The subject is not of childbearing potential and signed informed consent.

• Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.

Exclusion Criteria:

• The subject was previously included in this study.

• The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).

• The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.

• The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.

• The subject has gross haematuria.

• The subject has a history of porphyria.

Trial Contact Information

Trial Lead Organizations/Sponsors

GE Healthcare

Jean-Paul Antonini

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00785694
Information obtained from ClinicalTrials.gov on November 04, 2008