Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes
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ClinicalTrials.gov Identifier: NCT02371135 |
Recruitment Status :
Recruiting
First Posted : February 25, 2015
Last Update Posted : March 2, 2022
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Condition or disease | Intervention/treatment |
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Lynch Syndrome Hereditary Colonic Polyposis Syndromes | Genetic: colonic biopsies Genetic: questionnaires |
Study Type : | Observational |
Estimated Enrollment : | 225 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes |
Actual Study Start Date : | February 2015 |
Estimated Primary Completion Date : | February 2024 |
Estimated Study Completion Date : | February 2024 |

Group/Cohort | Intervention/treatment |
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patients having lower endoscopy
At least 2 weeks prior to scheduled lower endoscopy, consented study participants will be mailed a Brief Diet and Lifestyle Questionnaire, a stool collection kit with detailed instructions and a Stool Collection Data Sheet. No more than one week prior to the lower endoscopy but prior to initiation of bowel preparation, the consented participants will provide a stool specimen and fill out the two questionnaires. The routine lower endoscopy will be performed according to routine clinical procedures. Clinical biopsies of suspicious areas and/or lesions will be taken as per standard clinical care with all such tissue samples sent to pathology for routine clinical analysis. For the sole purposes of research, at the routine lower endoscopy, up to 8 additional colonic biopsies will be taken from normal appearing colon mucosa
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Genetic: colonic biopsies Genetic: questionnaires |
- 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) [ Time Frame: 2 years ]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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Male or Female age 18 or older
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371135
Contact: Zsofia Stadler, MD | 646-888-4615 | ||
Contact: Arnold Markowitz, MD | 212-639-2901 |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Zsofia Stadler, MD 646-888-4615 | |
Contact: Arnold Markowitz, MD 212-639-2901 | |
Principal Investigator: Zsofia Stadler, MD |
Principal Investigator: | Zsofia Stadler, MD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT02371135 |
Other Study ID Numbers: |
15-016 |
First Posted: | February 25, 2015 Key Record Dates |
Last Update Posted: | March 2, 2022 |
Last Verified: | March 2022 |
Gut Microbiome 15-016 |
Colorectal Neoplasms Nasopharyngeal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Syndrome Disease Pathologic Processes Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases |