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CompletedNCT03297996Updated Sep 29, 2017

Study of Gut Microbiome and Colorectal Tumors

An observational study in Serrated Polyp, Hyperplastic Polyp and Sessile Serrated Adenoma, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-29.

Sponsored by NYU Langone Health · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
540
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Serrated Polyp
  • Hyperplastic Polyp
  • Sessile Serrated Adenoma
  • Colorectal Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
540 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • SIT

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

    Diagnostic Test: Mobio PowerSoil DNA Isolation Kit

  • NYU

    New York University (NYU) Human Microbiome and Colorectal Tumor study

    Diagnostic Test: Mobio PowerSoil DNA Isolation Kit

Interventions

  • Diagnostic testMobio 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

05

What researchers measure

Primary outcomes

  1. Prevalence and relative abundance of selected fecal microbial taxa

    Quantitative polymerase chain reaction

    Time frame: 2 Days

06

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
07

Registry details

Key details

Study ID
NCT03297996
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Sep 29, 2017
Start date
Nov 23, 2011
Primary completion
Apr 25, 2015
Completion
Apr 25, 2015
Last update
Sep 29, 2017

Study contacts

Jiyoung Ahn, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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