Faecal Microbiota Characterization in Lynch Syndrome (LS) Patients With or Without Colorectal Neoplasia

NCT04791644 | Unknown

• 1 other identifier: APHP200136
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is the second cause of cancer-related death in western countries. CRC prevention and screening are major public health issues. Better knowledge of colorectal carcinogenesis could lead to better prevention. Gut microbiota (GM) is a complex community of bacteria, fungi, protozoa, viruses and bacteriophages which live in a symbiotic and epigenetic relationship with the host. GM can promote either digestive health or CRC through inflammatory and proliferative effects. Lynch syndrome (LS) is the most common familial CRC syndrome with a lifetime CRC risk of 52% in women and 69% in men. The risk of CRC depends upon type of altered mismatch-repair gene and environmental factors (diet, exercise, obesity, tobacco and alcohol intake, etc.). Regular surveillance including annual or biannual colonoscopy is recommended in LS patients. Chemoprevention has the potential to represent a cost-effective intervention in these high-risk patients and could allow a delay in colonoscopy surveillance. Regular low dose aspirin use is associated with a 20 to 30% reduction in the risk of sporadic colonic adenomas and CRC. The real benefit of aspirin is still to be consolidated. AAS-Lynch trial is an ongoing prospective multicenter (n=37), double-blind, placebo-controlled, randomized clinical trial, designed to investigate whether daily aspirin, at a dose of 100 or 300 mg compared with placebo, would decrease the occurrence or recurrence of colorectal adenomas in LS patients. The primary endpoint is the number of patients with at least one adenoma detected by chromo-endoscopy 48 months after initial colon clearance. At randomization and at the end of study, stool collection, blood collection, quality of life questionnaire, validated food frequency questionnaire (SU-VI-MAX2) and physical activity questionnaire are performed. The ongoing AAS-Lynch study allow accessing to a unique fecal collection in very well characterized LS patients including a comprehensive dietary evaluation at high risk for colorectal neoplasia and planned colonoscopy surveillance during a 48 months follow-up, exposed or not exposed to chronic low dose aspirin. The expertise of the scientific consortium with state of the art microbiota analysis, the comprehensive collection of data and the prospective design of the study will allow the evaluation of the true role of gut microbiota in CRC carcinogenesis.

Conditions

Lynch Syndrome

Outcome Measures

Primary Outcomes (1)

• This study will compare fecal microbiota richness and composition differences between LS patients with no previous adenoma at inclusion in AAS-Lynch study and LS patients with history of adenoma or adenoma at inclusion in AAS-Lynch study.

  This study will compare fecal microbiota richness and composition differences between LS patients with no previous adenoma at inclusion in AAS-Lynch study and LS patients with history of adenoma or adenoma at inclusion in AAS-Lynch study.

  4 years

Secondary Outcomes (1)

• Gut microbiota composition description

  4 years

Eligibility Criteria

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

Study Population

* Patient with Lynch syndrome bearing an alteration of "mismatch repair" genes or,when no characteristic alteration has been found, with a personal or family history of Lynch syndrome according to modified Amsterdam criteria * Aged more than 25 years, et aged more than 18 years with an early familial history and any reason to perform a colonoscopy every 2 years * Aged less than 75 years

You may qualify if:

• Patients included in the AAS-Lynch study (NCT02813824 on clinicaltrials.gov)
• Fecal samples taken for the AAS-Lynch study (NCT02813824 on clinicaltrials.gov)
• Food questionnaires collected as part of the AAS-Lynch study (NCT02813824 on clinicaltrials.gov)

You may not qualify if:

• Patients who did not included in the AAS-Lynch study (NCT02813824 on clinicaltrials.gov)
• Patients who did not consent for the Fecal samples in AAS-Lynch study (NCT02813824 on clinicaltrials.gov)
• Patients who did not do the Food questionnairy in AAS-Lynch study (NCT02813824 on clinicaltrials.gov)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Avicenne, AP-HP, Service de Gastroentérologie et Oncologie Digestive

Bobigny, Paris/Seine-Saint-Denis, 93000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal samples collection

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; 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

Study Officials

• Robert BENAMOUZIG, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert BENAMOUZIG, MD, PhD

CONTACT

33148957104; robert.benamouzig@aphp.fr

Mourad BENALLAOUA, PhD

CONTACT

33148955024; mourad.benallaoua@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 10, 2021
• Study Start: April 20, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 18, 2021

Record last verified: 2021-02

Locations

FR (1)