Endomicrocancer: Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer
Primary Purpose
Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Confocal endomicroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Inflammatory Bowel Disease (IBD) focused on measuring nflammatory bowel diseases (IBD), Familial adenomatous polyposis (FAP)
Eligibility Criteria
Inclusion criteria:
- For IBD: Clinically and histologically proven UC and Crohn's disease involving at least 30% of colon, with disease duration over 8 years for pancolitis or over 15 years for left colitis
- For FAP: patients at least 2 years after colectomy, with either rectal stump or ileal pouch
- Obtained signed informed consent
Exclusion criteria:
- For IBD: Active disease (only for cohort I a) : For UC: Colitis Activity index >= 8, Truelove and Witt's activity index: moderate or severe For CD: CDAI: > 150
- Known intraepithelial neoplasia or colorectal cancer or any other malignancy
- Coagulopathy
- Prothrombin time < 50% of control
- Platelet blood count < 70 000/mm²
- Impaired renal function (creatinine > 1.2 mg/dl)
- Pregnancy or breast-feeding
- Known allergy to indigo-carmin or fluorescein
Sites / Locations
- CHU de Lille
- Hôpital Saint Philibert
- Institut Paoli Calmettes
- CHU de Nantes
- Hôpital Lyon Sud
- CHU de Toulouse
Outcomes
Primary Outcome Measures
Evaluate and validate CEM in terms of its ability to diagnose neoplastic lesions and to distinguish between normal and neoplastic mucosa in vivo, based on comparison between "optical biopsies" and standard histology.
Secondary Outcome Measures
Full Information
NCT ID
NCT01052376
First Posted
January 19, 2010
Last Updated
May 22, 2012
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01052376
Brief Title
Endomicrocancer: Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer
Official Title
Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer: Potential for Diagnosis of Early Neoplasia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Terminated
Study Start Date
December 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The principle objective of this study is to validate confocal endomicroscopy (CEM) in a national, multicenter study, in terms of its ability to diagnose neoplastic lesions in vivo, in two groups of patients at high risk of colorectal cancer (CRC): patients with familial adenomatous polyposis (FAP) after colectomy in whom the neoplastic lesions are probably under-diagnosed, and patients with inflammatory bowel diseases (IBD) in whom endoscopic surveillance is particularly difficult. Methods: The study will be comprised of two phases (Phase I and II). Phase I will serve to validate at the multicenter level the results of the first, recently published, monocenter German study in terms of capacity of CEM to identify the colonic neoplastic lesions in vivo. Phase II is destined to prospectively evaluate the diagnostic yield of CEM in detection and prediction of neoplastic lesions by developing and adding new features to the confocal pattern of in vivo diagnosis. Two cohorts of patients will be studied in parallel: Patients with inflammatory bowel diseases (IBD), like ulcerative colitis (UC) or Crohn's disease (CD), including those before planned colectomy, and patients with FAP after colectomy. During lower endoscopy performed under general anaesthesia, each colonic segment will be examined before and after staining with indigo-carmin. After intra-venous fluorescein injection, all macroscopically abnormal lesions will be examined by CEM, then biopsied. In parallel, multiple random biopsies will be performed, each coupled with simultaneous CEM "optical biopsy" at the same point. In addition, during Phase II, in IBD patients before planned colectomy and in patients with FAP, a "mapping" of colonic mucosa, by obtaining a very high number of CEM "optical biopsies", will be performed, and will be correlated with standard histology performed either on colectomy specimens (IBD) or on standard biopsies (FAP). Principal analysis (Phase I and II) will include evaluation of inter-observer variation in terms of interpretation of in vivo histology and diagnostic yield of CEM with respect to the detection of neoplastic lesions by evaluation of sensitivity and specificity, using standard histology as reference method. Additional analysis (Phase II) will be performed to evaluate the diagnostic and predictive (CRC risk) value of "colonic mapping" by correlating optical images pattern score to results of standard histology. Expected results: This study should guarantee high quality data, standardization of procedures and of interpretation of CEM images, which are prerequisite for dissemination of CEM in clinical practice. The investigators expect to show that CME allows to reliably discriminate between neoplastic and non-neoplastic lesions, that, compared to standard histology, provides better characterization of lesions, especially in the context of extended lesions like in IBD, an finally, that CME images can be used to develop a new "optical biopsy"-based score allowing prediction of high CRC risk in patients with FAP and IBD. The investigators believe that CEM may increase, as compared to currently used techniques, the diagnostic yield in terms of probability of the detection of neoplastic lesions in patients at high risk of CCR, and may become a new standard for endoscopic surveillance in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis
Keywords
nflammatory bowel diseases (IBD), Familial adenomatous polyposis (FAP)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Confocal endomicroscopy
Primary Outcome Measure Information:
Title
Evaluate and validate CEM in terms of its ability to diagnose neoplastic lesions and to distinguish between normal and neoplastic mucosa in vivo, based on comparison between "optical biopsies" and standard histology.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
For IBD: Clinically and histologically proven UC and Crohn's disease involving at least 30% of colon, with disease duration over 8 years for pancolitis or over 15 years for left colitis
For FAP: patients at least 2 years after colectomy, with either rectal stump or ileal pouch
Obtained signed informed consent
Exclusion criteria:
- For IBD: Active disease (only for cohort I a) : For UC: Colitis Activity index >= 8, Truelove and Witt's activity index: moderate or severe For CD: CDAI: > 150
Known intraepithelial neoplasia or colorectal cancer or any other malignancy
Coagulopathy
Prothrombin time < 50% of control
Platelet blood count < 70 000/mm²
Impaired renal function (creatinine > 1.2 mg/dl)
Pregnancy or breast-feeding
Known allergy to indigo-carmin or fluorescein
Facility Information:
Facility Name
CHU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Saint Philibert
City
Lomme
ZIP/Postal Code
59462
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Endomicrocancer: Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer
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