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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02371135
Recruitment Status : Recruiting
First Posted : February 25, 2015
Last Update Posted : March 2, 2022
Sponsor:
Collaborators:
Harvard University
Broad Institute
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Lynch Syndrome Hereditary Colonic Polyposis Syndromes Genetic: colonic biopsies Genetic: questionnaires

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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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Genetic: colonic biopsies
Genetic: questionnaires



Primary Outcome Measures :
  1. 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
tissue stool


Information from the National Library of Medicine

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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
Study Population
Potential research subjects will be identified prospectively within the clinics of the Clinical Genetics and Gastroenterology Services, of MSKCC.
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Zsofia Stadler, MD 646-888-4615
Contact: Arnold Markowitz, MD 212-639-2901

Locations
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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         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Harvard University
Broad Institute
Investigators
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Principal Investigator: Zsofia Stadler, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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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
Keywords provided by Memorial Sloan Kettering Cancer Center:
Gut Microbiome
15-016
Additional relevant MeSH terms:
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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