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Study of Gut Microbiome and Colorectal Tumors

NCT ID: NCT03297996

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-23

Study Completion Date

2015-04-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Serrated Polyp Hyperplastic Polyp Sessile Serrated Adenoma Colorectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SIT

Centers for Disease Control and Prevention (CDC) Study of In-home Tests for Colorectal Cancer (SIT)

Mobio PowerSoil DNA Isolation Kit

Intervention Type DIAGNOSTIC_TEST

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

Mobio PowerSoil DNA Isolation Kit

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiyoung Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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11-01377

Identifier Type: -

Identifier Source: org_study_id