NCT00352404

Brief Summary

Timely diagnosis of intraepithelial neoplasias (premalignant condition)is of crucial importance for clinical management of ulcerative colitis. We assessed the value of combined chromoscopy and endomicroscopy for diagnosis of intraepithelial neoplasias in a randomised controlled trial. Endomicroscopy is a new device which enables microscopy of the mucosal layer during ongoing colonoscopy. Chromoscopy means topical staining of mucosal surface to unmask areas of interest, which are subsequently examined with the endomicroscopic system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
Last Updated

July 14, 2006

Status Verified

August 1, 2003

First QC Date

July 13, 2006

Last Update Submit

July 13, 2006

Conditions

Ulcerative ColitisIntraepithelial NeoplasiaCancer

Keywords

EndomicroscopyChromoendoscopyChromoscopyUlcerative ColitisIntraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

  • Histological proof of neoplastic tissue (Intraepithelial neoplasia or cancer)

Secondary Outcomes (1)

  • Prediction of extent and severity of inflamed mucosa

Interventions

EndomicroscopeDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically and histologically verified UC
  • Disease duration \>8 years
  • Colitis Activity Index ≤8
  • Activity index of Truelove and Witts: mild

You may not qualify if:

  • Known intraepithelial neoplasia or colorectal cancer
  • Coagulopathy (Prothrombin time \<50% of control, Partial thromboplastin time \>50 s)
  • Impaired renal function (Creatinine \>1.2 mg/dL)
  • Pregnancy or breast feeding
  • Inability to obtain informed consent
  • Known allergy to methylene blue or Fluorescein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I. Med. Klinik, Johannes Gutenberg Universitaet

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Links

MeSH Terms

Conditions

Colitis, UlcerativeCarcinoma in SituNeoplasms

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Peter R. Galle, MD PhD

    Johannes Gutenberg University, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 14, 2006

Study Start

August 1, 2003

Study Completion

November 1, 2004

Last Updated

July 14, 2006

Record last verified: 2003-08

Locations

DE(1)