CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome

NCT00224601 | Completed Phase 2

• 1 other identifier: P040423
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Keywords

Colorectal cancer; HNPCC; Diagnosis; Coloscopy; Chromoscopy; Indigo carmine; Colorectal Neoplasms; Hereditary Nonpolyposis

Outcome Measures

Primary Outcomes (1)

• Number of pre-cancer lesions or early cancer detected.

  during the procedure

Secondary Outcomes (1)

• Anatomopathologic criteria (size of lesions, …).

  during the procedure

Interventions

Colonoscopy with chromoscopy PROCEDURE

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with MLH1, MSH2 or MSH6 mutation.
• Patients concerned by early detection colonoscopy.

You may not qualify if:

• Coloscopy of tracking since less 1an
• occlusive Syndrome contra-indicating the preparation for a total coloscopies
• Colectomies
• medical Conditions or serious illnesses contra-indicating a coloscopy of screening
• pregnant Woman or nursing
• Anomaly of coagulation contra-indicating the realization of biopsies and/or the exeresis of the lesion colorectal

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Europeen Georges Pompidou

Paris, Île-de-France Region, 75015, France

Location

Related Publications (1)

• Mention JJ, Ben Ahmed M, Begue B, Barbe U, Verkarre V, Asnafi V, Colombel JF, Cugnenc PH, Ruemmele FM, McIntyre E, Brousse N, Cellier C, Cerf-Bensussan N. Interleukin 15: a key to disrupted intraepithelial lymphocyte homeostasis and lymphomagenesis in celiac disease. Gastroenterology. 2003 Sep;125(3):730-45. doi: 10.1016/s0016-5085(03)01047-3.

  PMID: 12949719 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Colorectal Neoplasms; Disease

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Christophe CELLIER, Pr,MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 23, 2005
• Study Start: July 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: February 18, 2011

Record last verified: 2007-07

Locations

FR (1)