Confocal Laser Endomicroscopy in the Lower Urinary Tract

NCT03013894 | Completed

• 1 other identifier: 2015_300
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up of primary and recurrent bladder cancer have some limitations. CLE, a high resolution imaging technique, that can be used combined with endo-urological procedures, seems promising to improve diagnosis of bladder cancer. The diagnostic accuracy of cystoscopic applied confocal laser endomicroscopy (CLE) still has to be defined. Objective: To directly correlate CLE images with histopathology, and identify and define CLE characteristics of normal urothelium, benign bladder urothelium, and bladder tumors (low-grade, high-grade and carcinoma in situ (CIS)) of the lower urinary tract. Primary objective: to develop descriptive image interpretation criteria and a classification of CLE images of bladder tissue through a review of prospectively obtained CLE videos from bladder tissue correlated with histopathology. Secondary objectives:

• Assessing procedure related adverse events of CLE
• Assessing technical feasibility of CLE
• To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign, low-grade or high-grade and CIS)

Conditions

Bladder Neoplasm; Urothelial Carcinoma

Keywords

bladder neoplasm; urothelium carcinoma; confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

• Confocal laser endomicroscopy characteristics of urothelium of the lower urinary tract

  Qualitatively correlating CLE images to histopathology to define CLE characteristics

  1.5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients \>18 years old with primary or recurrent bladder tumor(s), who are scheduled for TURB are eligible for this study.

You may qualify if:

• Patients \>18 years old
• Bladder tumor(s)
• Candidate for TURB
• Signed informed consent

You may not qualify if:

• Patients \<18 years old
• Patients with known allergy for fluorescein
• Possible pregnancy or lactating women
• No signed informed consent

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

Related Publications (1)

• Liem EI, Freund JE, Baard J, de Bruin DM, Laguna Pes MP, Savci-Heijink CD, van Leeuwen TG, de Reijke TM, de la Rosette JJ. Confocal Laser Endomicroscopy for the Diagnosis of Urothelial Carcinoma in the Bladder and the Upper Urinary Tract: Protocols for Two Prospective Explorative Studies. JMIR Res Protoc. 2018 Feb 7;7(2):e34. doi: 10.2196/resprot.8862.

  PMID: 29415874 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

CLE images (without DNA) and histopathology (with DNA)

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jean J de la Rosette, prof. dr.

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 9, 2017
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)