Study of Gut Microbiome and Colorectal Tumors

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03297996
• Collaborator: (none)
• Enrollment: 540
• Location: 1
• Actual Duration (Months): 41
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Serrated Polyp; Hyperplastic Polyp; Sessile Serrated Adenoma; Colorectal Cancer	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 Design

• Study Type: Observational
• Actual Enrollment: 540 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer
• Actual Study Start Date: Nov 23, 2011
• Actual Primary Completion Date: Apr 25, 2015
• Actual Study Completion Date: Apr 25, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Prevalence and relative abundance of selected fecal microbial taxa [2 Days]

   Quantitative polymerase chain reaction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Jiyoung Ahn, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03297996
• Other Study ID Numbers: 11-01377
• First Posted: Sep 29, 2017
• Last Update Posted: Sep 29, 2017
• Last Verified: Sep 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms; Adenoma; Polyps

Study Results

No Results Posted as of Sep 29, 2017