- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01052376
Endomicrocancer: Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer
May 22, 2012 updated by: Nantes University Hospital
Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer: Potential for Diagnosis of Early Neoplasia
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lille, France, 59037
- CHU de Lille
-
Lomme, France, 59462
- Hopital Saint Philibert
-
Marseille, France, 13009
- Institut Paoli Calmettes
-
Nantes, France, 44093
- CHU de Nantes
-
Pierre-Bénite, France, 69495
- Hopital Lyon Sud
-
Toulouse, France, 31059
- CHU de Toulouse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Study Completion (ACTUAL)
January 1, 2011
Study Registration Dates
First Submitted
January 19, 2010
First Submitted That Met QC Criteria
January 19, 2010
First Posted (ESTIMATE)
January 20, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
May 23, 2012
Last Update Submitted That Met QC Criteria
May 22, 2012
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Gastroenteritis
- Colonic Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Neoplastic Syndromes, Hereditary
- Adenomatous Polyps
- Adenoma
- Intestinal Polyposis
- Inflammatory Bowel Diseases
- Intestinal Diseases
- Adenomatous Polyposis Coli
Other Study ID Numbers
- BRD08/6-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Familial Adenomatous Polyposis
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...CompletedFamilial Adenomatous Polyposis (FAP)Italy
-
M.D. Anderson Cancer CenterCompletedAttenuated Familial Adenomatous Polyposis | Deleterious Familial Adenomatous PolyposisUnited States
-
PfizerTerminatedFamilial Adenomatous Polyposis (FAP)United States, Spain, Canada, Denmark
-
National Cancer Institute (NCI)RecruitingFamilial Adenomatous Polyposis | Colorectal Carcinoma | Attenuated Familial Adenomatous Polyposis | Duodenal CarcinomaUnited States, Puerto Rico
-
Copenhagen University Hospital, HvidovreCompletedDuodenal Cancer | Duodenal Polyposis | Familial Adenomatous PolyposesDenmark
-
michal rollUnknownFAP-Familial Adenomatous Polyposis
-
National Cancer Institute (NCI)CompletedFamilial Adenomatous Polyposis | Attenuated Familial Adenomatous PolyposisUnited States, Puerto Rico
-
S.L.A. Pharma AGCompletedFAP | Familial Adenomatous Polyposis ColiUnited Kingdom
-
michal rollUnknownFAP-Familial Adenomatous PolyposisIsrael
-
Dr. Ersin Arslan Education and Training HospitalCompleted
Clinical Trials on Confocal endomicroscopy
-
University of AlbertaCompleted
-
Fauze Maluf FilhoCompletedHead and Neck Neoplasms | Esophageal Neoplasms | Colorectal Polyps | Barrett Esophagus | Pancreatic Duct Stricture | Gastric Antrectomy Partial | Biliary Duct StrictureBrazil
-
Medical University of ViennaCompleted
-
Medical University of ViennaUnknown
-
Nanfang Hospital, Southern Medical UniversityRecruiting
-
Taipei Veterans General Hospital, TaiwanRecruitingGastrointestinal Post Acute COVID-19 SyndromeTaiwan
-
University of Erlangen-Nürnberg Medical SchoolCompletedEosinophilic EsophagitisGermany
-
Eye & ENT Hospital of Fudan UniversityUnknownLaryngeal Leiomyoma | Probe-based Confocal Laser EndomicroscopyChina
-
Herlev HospitalCompleted
-
University of Medicine and Pharmacy CraiovaCopenhagen University Hospital at HerlevTerminatedCrohn's Disease | Ulcerative Colitis | Inflammatory Bowel Disease | DysplasiaRomania