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NCT02371135Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 5 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
77 (actual)
First submitted
19 Feb 2015
Start date
Feb 2015
Primary completion date
Feb 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT02371135

What you commit to

  • Study type: Observational
  • Participants enrolled: 77
  • From Feb 2015 to the primary completion date, Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • No history of inflammatory colitis (Crohn's disease or ulcerative colitis)

Other

  • Unable to provide informed consent for testing
  • Unable to complete English language questionnaire

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.