Study of Gut Microbiome and Colorectal Tumors
The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer
1 other identifier
observational
540
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2015
CompletedFirst Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
September 29, 2017
CompletedSeptember 29, 2017
September 1, 2017
3.4 years
September 27, 2017
September 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence and relative abundance of selected fecal microbial taxa
Quantitative polymerase chain reaction
2 Days
Study Arms (2)
SIT
Centers for Disease Control and Prevention (CDC) Study of In-home Tests for Colorectal Cancer (SIT)
NYU
New York University (NYU) Human Microbiome and Colorectal Tumor study
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
Biospecimen
DNA was extracted from stool using the PowerLyzer PowerSoil Kit (Mo Bio Laboratory Inc., CA) following the manufacturer's protocol. DNA was collected and eluted using silica columns included with the PowerLyzer PowerSoil kit. Barcoded amplicons were generated covering the V4 region of the 16S rRNA gene using the F515/R806 primer pair.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiyoung Ahn, MD
NYU Langone Health
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2017
First Posted
September 29, 2017
Study Start
November 23, 2011
Primary Completion
April 25, 2015
Study Completion
April 25, 2015
Last Updated
September 29, 2017
Record last verified: 2017-09