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NCT00874263 · ClinicalTrials.gov registry record

Confocal Probe-based Endoscopic Imaging, Colorectal Cancer, Gastrointestinal (GI) Pathologies

A clinical trial of Colonic Polyps and Esophageal Diseases, sponsored by Mayo Clinic.

Completed
Registry status
225
Enrollment target
1
Study location

NCT00874263 is a study of Colonic Polyps and Esophageal Diseases that has completed, run by Mayo Clinic. The registered enrollment target is 225 participants, below the 752-participant average among 6 other Colonic Polyps trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00874263, a study of Colonic Polyps and Esophageal Diseases, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
225 participants
Enrollment target
1
Study location

Study Summary

The recently developed endoscopic Confocal probe microscopy system allows imaging of surface epithelium during ongoing endoscopy (upper and lower) with the potential of immediate diagnosis of various GI pre-malignant and malignant lesions. The purpose of this study is to determine if using this new Confocal probe system can find pre-cancerous abnormalities in the stomach and colon. Hypothesis: The confocal endomicroscopy images of colorectal lesions during the standard colonoscopies could help the classification in vivo of colorectal neoplastic and non-neoplastic lesions. This could direct further endoscopic interventions such as targeted biopsies of early colorectal cancer lesions and the endoscopic resection of such lesions during screening colonoscopies. Primary Aim 1. To determine the key confocal image features of neoplastic and pre-neoplastic colorectal lesions including flat and raised adenomatous polyps, intraepithelial neoplasia and cancer as well as benign lesions such as hyperplastic polyps and normal colonic epithelium and to estimate which morphologic features best distinguish neoplastic and non-neoplastic tissues. Secondary Aims: 2. To determine the initial sensitivity and specificity of confocal microendoscopy imaging for classification of adenomatous from hyperplastic polyps of the colon. 3. In this exploratory phase of the study to develop a library of confocal microendoscopic imaging characteristics of other GI pathologies such as: 1. Barrett's esophagus in comparison to Barrett's esophagus with dysplasia, and normal squamous esophagus. 2. Other encountered inflammatory and neoplastic conditions within the GI tract in which biopsy or removal of tissue would routinely be indicated. The second phase of the study will focus on establishing the sensitivities, specificities, accuracy of confocal images of colorectal lesions and other GI pathologies as well as inter-observer agreement and learning curve in interpretation of confocal images

Study Locations (1)

Florida

  • Mayo Clinic - Jacksonville

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2008-03
Est. Completion 2012-06

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT00874263

The ClinicalTrials.gov registry entry for NCT00874263 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 752-participant average among 6 other Colonic Polyps trials with a reported enrollment target (70% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Colonic Polyps appearing as the primary indexed condition, and to 0 interventions.

NCT00874263 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT00874263 about?

NCT00874263 is a clinical study titled "Confocal Probe-based Endoscopic Imaging, Colorectal Cancer, Gastrointestinal (GI) Pathologies". The recently developed endoscopic Confocal probe microscopy system allows imaging of surface epithelium during ongoing endoscopy (upper and lower) with the potential of immediate diagnosis of various GI pre-malignant and malignant lesions. The purpose of this study is to determine if using this new ...

What is the current status of trial NCT00874263?

This trial is currently completed. The enrollment target is 225 participants. The study started on 2008-03. Estimated completion is 2012-06.

What conditions does trial NCT00874263 study?

This clinical trial studies the following conditions: Colonic Polyps, Esophageal Diseases.

Who is sponsoring clinical trial NCT00874263?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00874263 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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