Confocal Probe-based Endoscopic Imaging, Colorectal Cancer, Gastrointestinal (GI) Pathologies
Public ClinicalTrials.gov record NCT00874263. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Role of Endoscopic Confocal Microscopy in Diagnosing Colorectal Cancer and Other Gastrointestinal Pathologies in Vivo
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00874263
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2008
- Primary completion
- Nov 30, 2010
- Completion
- May 31, 2012
- Last update posted
- Jun 21, 2012
2008 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00874263, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 21, 2012 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00874263 live on ClinicalTrials.gov.