Study of Gut Microbiome and Colorectal Tumors

The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer

Gut microbiota were assessed in 540 colonoscopy-screened adults by 16S rRNA gene sequencing of stool samples. Investigators compared gut microbiota diversity, overall composition, and normalized taxon abundance among these groups.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Serrated Polyp; Sessile Serrated Adenoma; Hyperplastic Polyp
• Intervention / Treatment: Diagnostic test: Mobio PowerSoil DNA Isolation Kit

Detailed Description

Colorectal cancer is a heterogeneous disease arising from at least two precursors-the conventional adenoma (CA) and the serrated polyp. A relationship between the human gut microbiota and colorectal cancer has been shown; however, its relationship to the different early precursors of colorectal cancer is understudied. This study tested, for the first time, the relationship of the gut microbiota to specific colorectal polyp types.

• Study Type: Observational
• Enrollment (Actual): 540

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

There are no enrollment restrictions based on race or ethnic origins. Vulnerable subjects such as pregnant women and children will not be involved in this study. We will not ask subjects about sensitive topics such as Mental Health, drug/alcohol abuse, or others that fall in this category.

Description

Inclusion Criteria:

• Both men and women who have visited a gastroenterologist or surgeon, aged 18 or older will be included in this study.
• Both men and women residents in the United States, aged 18 or older will be included in this study.

Exclusion Criteria:

• Women who are pregnant will be excluded from participating in this study
• Subjects on ongoing antibiotic therapy will be excluded from participating in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SIT; Centers for Disease Control and Prevention (CDC) Study of In-home Tests for Colorectal Cancer (SIT)	Diagnostic test: Mobio PowerSoil DNA Isolation Kit; 16S rRNA amplicons covering variable regions V3 to V4 were generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3') incorporating Roche 454 FLX Titanium adapters (Branford, CT) and a sample barcode sequence
NYU; New York University (NYU) Human Microbiome and Colorectal Tumor study	Diagnostic test: Mobio PowerSoil DNA Isolation Kit; 16S rRNA amplicons covering variable regions V3 to V4 were generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3') incorporating Roche 454 FLX Titanium adapters (Branford, CT) and a sample barcode sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence and relative abundance of selected fecal microbial taxa	Quantitative polymerase chain reaction	2 Days

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2011
• Primary Completion (Actual): April 25, 2015
• Study Completion (Actual): April 25, 2015

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma; Polyps
• Other Study ID Numbers: 11-01377

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No