Bladder CancerNCT00213655
URO-BCG-4 : Bladder Tumors Immunotherapy
An observational study of Bladder Cancer, run by University Hospital, Rouen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- bladder tumor recurrence
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2004to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Bladder Cancer
Who may be able to join
- Ta and T1 bladder tumors
Who cannot join
- BCG contra-indications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors
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.
Read the 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
- Conditions
- Bladder Cancer
- Being tested
- bladder tumor recurrence
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bladder tumor recurrenceBiological
bladder tumor recurrence assessed by clinical and biological exams
| Study group | Role | What they receive |
|---|---|---|
| Daily instillation of BCG for 3 weeks then every 6 months | Effect of daily instillation of BCG (27 mg) for 3 weeks then one instillation of BCG (27 mg) every 6 months for 36 months on bladder tumor recurrence Receives: Biological: bladder tumor recurrence | |
| Daily instillation of BCG for 2 weeks then every 3 months | Effect of daily instillation of BCG (27 mg) for 2 weeks then one instillation of BCG (27 mg) every 3 months for 36 months on bladder tumor recurrence Receives: Biological: bladder tumor recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumoral response
Tumoral response assessed at M36
Measured: Month 36
Secondary outcomes (1)
Tumoral response
Tumoral response assessed at M24
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian PFISTER, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213655
- Sponsor's protocol ID
- 2003/081/HP
- Status last verified
- Jul 2014
- First submitted
- 14 Sep 2005
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors
- ClinicalTrials.gov ID
- NCT00213655
- Acronym / sponsor ID
- 2003/081/HP
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily instillation of BCG for 3 weeks then every 6 months | – | Biological: bladder tumor recurrenceEffect of daily instillation of BCG (27 mg) for 3 weeks then one instillation of BCG (27 mg) every 6 months for 36 months on bladder tumor recurrence |
| Daily instillation of BCG for 2 weeks then every 3 months | – | Biological: bladder tumor recurrenceEffect of daily instillation of BCG (27 mg) for 2 weeks then one instillation of BCG (27 mg) every 3 months for 36 months on bladder tumor recurrence |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Bladder Cancer
Key inclusion criteria (1 listed)
- Ta and T1 bladder tumors
Key exclusion criteria (1 listed)
- BCG contra-indications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bladder tumor recurrencebladder tumor recurrence assessed by clinical and biological exams | Biological | Daily instillation of BCG for 2 weeks then every 3 months, Daily instillation of BCG for 3 weeks then every 6 months |
Primary outcome
Tumoral response
Time frame: Month 36
Tumoral response assessed at M36
1 secondary outcome
Tumoral response
Time frame: Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian PFISTER, MD, PhD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumoral response (time frame: Month 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014.