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URO-BCG-4 : Bladder Tumors Immunotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2004 by University Hospital, Rouen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213655
First received: September 14, 2005
Last updated: NA
Last verified: March 2004
History: No changes posted
  Purpose

Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.


Condition Intervention Phase
Bladder Cancer
 Biological: bladder tumor recurrence
 Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Estimated Enrollment: 300
Detailed Description:

BCG maintenance immunotherapy 1/3 dose : 27 mg two randomized arms : 3 or 6 months for 36 months clinical side effects according to OMS score efficacy regarding recurrence : cytology and cystoscopy PSA, leucocyturia and N-ramp gene evaluation

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ta and T1 bladder tumors

Exclusion Criteria:

  • BCG contra-indications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213655

Contacts
Contact: Delegation Recherche Clinique Rouen University Hospital 0033232888265 Delegation.Recherche@chu-rouen.fr

Locations
France
Charles Nicolle, University Hospital Recruiting
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Christian PFISTER, MD, PhD Rouen University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00213655     History of Changes
Other Study ID Numbers: 2003/081/HP
Study First Received: September 14, 2005
Last Updated: September 14, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013