The Accuracy of Optic Biopsies Versus Conventional Biopsies for the Diagnosis of Superficial Bladder Neoplasia
The Accuracy of Probe-based Confocal Laser Endomicroscopy Versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Bladder Neoplasia.
1 other identifier
interventional
189
1 country
1
Brief Summary
This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic of non-invasive flat and exophytic bladder neoplasia. CLE results are compared to histopathology results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 6, 2018
March 1, 2018
1.3 years
July 7, 2016
March 5, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
accordance between CLE and histology in flat bladder tumors
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in flat bladder neoplasia
An average of 18 months
Accordance between CLE and histology in exophytic bladder tumors
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in exophytic bladder neoplasia
An average of 18 months
Secondary Outcomes (2)
Accordance between CLE assessed by the surgeon and histology.
An average of 18 months
Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon
An average of 18 months
Study Arms (2)
CLE
OTHERCLE assessed by the pathologist
Biopsy
ACTIVE COMPARATORHistology assessed by the pathologist
Interventions
Patients scheduled for bladder endoscopic surgery under general anesthesia are offered to be included in our study. The suspicious mucosal areas are marked then examined with CLE. Tissue samples are taken based on the usual standard criterias. The samples are evaluated microscopically and compared with the results of the CLE technique. A single surgeon performs all surgeries. Biopsies are anlysed by a pathologist from Herlev and Gentofte Hospital's Pathology Department, which is affiliated CLE- study.
Eligibility Criteria
You may qualify if:
- First time Transurethral Resection of Bladder (TURB) for bladder tumors under 3 cm
- Suspicious mucosa / Carcinoma in situ
- Recurrent pTa
- Positive cytology with normal flexible cystoscopy
- Control after Bacille Calmette Guérin (BCG) treatment
You may not qualify if:
- Allergy to fluorescein
- Pregnant and lactating women.
- Renal failure (eGFR \<20 ml / min)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
Study Sites (1)
Urology department
Herlev, 2730, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sami Beji, MD
Herlev Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
July 7, 2016
First Posted
July 22, 2016
Study Start
June 1, 2018
Primary Completion
September 1, 2019
Study Completion
December 1, 2019
Last Updated
March 6, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share