Study of Gut Microbiome and Colorectal Tumors | NCT03297996

Studies
Study of Gut Microbiome and Colorectal Tumors

NCT03297996

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Sep 29, 2017Actual

Enrollment

540Actual

Phase

Not provided

Conditions

Serrated Polyp
Hyperplastic Polyp
Sessile Serrated Adenoma
Colorectal Cancer

Interventions

Mobio PowerSoil DNA Isolation Kit

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 23, 2011Actual

Primary Completion Date

Apr 25, 2015Actual

Completion Date

Apr 25, 2015Actual

First Submitted Date

Sep 27, 2017

First Submission Date that Met QC Criteria

Sep 28, 2017

First Posted Date

Sep 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2017

Last Update Posted Date

Sep 29, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

540Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Mobio PowerSoil DNA Isolation Kit	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jiyoung Ahn, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.