Know Cancer

or
forgot password

Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer: Potential for Diagnosis of Early Neoplasia


N/A
18 Years
75 Years
Not Enrolling
Both
Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis

Thank you

Trial Information

Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer: Potential for Diagnosis of Early Neoplasia

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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.

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD08/6-A

NCT ID:

NCT01052376

Start Date:

December 2008

Completion Date:

January 2011

Related Keywords:

  • Inflammatory Bowel Disease (IBD)
  • Familial Adenomatous Polyposis
  • nflammatory bowel diseases (IBD)
  • Familial adenomatous polyposis (FAP)
  • Colorectal Neoplasms
  • Inflammatory Bowel Diseases
  • Intestinal Diseases
  • Adenomatous Polyposis Coli

Name

Location