- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334314
Olfactive Detection of Urothelial Carcinoma by Sniffer Dogs (OUAF)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Victor GAILLARD
- Phone Number: +33 3 69 55 10 55
- Email: victor.gaillard@chru-strasbourg.fr
Study Locations
-
-
-
Colmar, France
- Recruiting
- Hôpitaux Civils de Colmar
-
Contact:
- Marc SCHNEIDER
- Phone Number: +33 3 89 12 49 93
- Email: schneidermarc1@gmail.com
-
Contact:
- Email: schneidermarc1@gmail.com
-
Principal Investigator:
- Marc SCHNEIDER
-
Strasbourg, France
- Recruiting
- Hôpitaux universitaires de Strasbourg
-
Contact:
- Victor GAILLARD
- Phone Number: +33 3 69 55 10 55
- Email: victor.gaillard@chru-strasbourg.fr
-
Principal Investigator:
- Victor GAILLARD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Subject scheduled for any endourological surgery involving an initial cystoscopy, the most common of which are: transurethral resection of the bladder, transurethral resection of the prostate, internal optical urethrotomy, bladder lithoclast, ureteral stent replacement, ureteroscopy, etc. (non-exhaustive list).
Recruitment will take place in the urology department, during the preoperative consultation or during hospitalization.
Description
Inclusion Criteria:
- Adult (> 18 years old)
- Subject scheduled for any endourological surgery involving an initial cystoscopy, the most common of which are: transurethral resection of the bladder, transurethral resection of the prostate, internal optical urethrotomy, bladder lithoclast, ureteral stent replacement, ureteroscopy, etc. (non-exhaustive list)
- Subjects for whom a urine sample (for bacteriological or cytological testing) is planned as part of routine practice in the month prior to the procedure
- Subjects affiliated with a health insurance plan or beneficiaries of such a plan
Exclusion Criteria:
- Absence of signed informed consent / inability to provide the subject with informed information (emergency situations, difficulties in understanding the subject, etc.)
- Patient under guardianship, conservatorship, or judicial protection
- History of cancer other than urothelial bladder carcinoma, unless in complete remission for > 5 years
- Pregnant or breastfeeding women
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Positive bladder tumor
Bladder tumor present during cystoscopy and confirmed by pathological examination.
|
olfactory detection of urothelial carcinoma of the bladder in a urine sample by dogs
|
|
Negative bladder tumor
No bladder tumor on cystoscopy/suspicious lesion but with negative pathological analysis
|
olfactory detection of urothelial carcinoma of the bladder in a urine sample by dogs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assess the sensitivity of olfactory detection of urothelial carcinomas of the bladder in urine samples by assistance dogs trained for this purpose
Time Frame: Day -60 to Day 0
|
Day -60 to Day 0
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9630
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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