Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes

Lynch Syndrome Clinical Trial

Official title:

Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02371135
• Other study ID #: 15-016
• Status: Active, not recruiting
• Start date: February 2015
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to understand the role bacteria that normally live in the colon may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer. The investigators will collect stool specimens as well as additional colon biopsy specimens during the patient's scheduled colonoscopy procedure. The investigators will also collect a questionnaire about diet and lifestyle. The samples will be used to study the impact of diet on naturally-occurring oral and gut bacteria and their influences on human health including risk of cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 77
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or Female age 18 or older
• Hereditary colorectal cancer syndrome with one of the following:
• Lynch syndrome, as defined by the presence of a deleterious germline mutation in the MLH1, MSH2, MSH6, PMS2 or EPCAM genes
• Other hereditary colonic polyposis syndromes, as defined by the presence of a deleterious germline mutation in any one of the following polyposis genes (APC, biallelic MYH, STK11, SMAD4, BMPR1A, or other CRC-risk associated genes at discretion of PI)

Exclusion Criteria:

• Unable to provide informed consent for testing
• Unable to complete English language questionnaire
• Receiving active chemotherapy
• Having completed active chemotherapy less then 12 months prior to day of scheduled lower endoscopy
• No infectious or drug induced colitis less then 12 months prior to day of scheduled lower endoscopy
• No history of inflammatory colitis (Crohn's disease or ulcerative colitis)

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Hereditary Colonic Polyposis Syndromes
• Lynch Syndrome
• Nasopharyngeal Neoplasms
• Syndrome

Intervention

Genetic:
• colonic biopsies

• questionnaires

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Broad Institute, Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	association of the gut microbiome and dietary factors (To validate said associations, individual questions from the Brief Diet and Lifestyle Questionnaire will be primarily used in the overall analyses)	with risk of adenoma or cancer in Lynch syndrome and other hereditary colonic polyposis syndrome patients. To validate said associations, individual questions from the Brief Diet and Lifestyle Questionnaire will be primarily used in the overall analyses.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center