CLE Characteristics of Upper Urinary Tract Urothelial Carcinoma

NCT03013920 | Completed

• 1 other identifier: 2016_088
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Initial evaluation usually consists of cross sectional imaging of the urinary tract. When a suspect lesion is seen, an ureterorenoscopy is planned to visualize the lesion and to collect tissue for histopathology. These techniques are considered to be the gold standard in diagnosis of UTUC. CLE, a high resolution imaging technique that can be used in combination with endo-urological procedures, seems promising to improve diagnosis of urothelial cancer. CLE image characteristics for UTUC still have to be defined. Objective: With this IDEAL stage 2b explorative pilot study the investigators aim to assess in-vivo CLE image characteristics of normal urothelium, benign urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract by qualitatively comparing CLE images with both histopathology from diagnostic biopsies and pathology from the therapeutic radical nephroureterectomy. Secondary objectives are the development of an imaging atlas and to assess the technical feasibility and procedure related adverse events of CLE.

Conditions

Urinary Tract Cancer; Urothelial Carcinoma; Ureter Cancer

Keywords

upper urinary tract cancer; confocal laser endomicroscopy; urothelial carcinoma

Outcome Measures

Primary Outcomes (1)

• In-vivo CLE measurements of normal urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract

  The CLE measurements are qualitatively correlated to the corresponding histopathology

  3 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

Adult patients with a suspect tumour in the upper urinary tract, who are planned for a diagnostic URS, are eligible for this study.

You may qualify if:

• Patients \>18 years
• Suspect upper urinary tract urothelial carcinoma
• Scheduled for diagnostic URS
• Signed informed consent

You may not qualify if:

• Patients \<18 years
• Patients with known allergy for fluorescein
• Possible pregnancy or lactating women
• Patients not eligible for radical treatment of UTUC
• 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 and histopathology

MeSH Terms

Conditions

Urologic Neoplasms; Carcinoma, Transitional Cell; Ureteral Neoplasms

Condition Hierarchy (Ancestors)

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

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: Prof. dr. JJMCH de la Rosette

Study Record Dates

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

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)