Serrated PolypNCT03297996
Study of Gut Microbiome and Colorectal Tumors
An observational study of Serrated Polyp and Hyperplastic Polyp, run by NYU Langone Health at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serrated Polyp, Hyperplastic Polyp, Sessile Serrated Adenoma
- What is being tested?
- Mobio PowerSoil DNA Isolation Kit
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2011to 25 Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer
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.
- Being tested
- Mobio PowerSoil DNA Isolation Kit
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobio PowerSoil DNA Isolation KitDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| SIT | Centers for Disease Control and Prevention (CDC) Study of In-home Tests for Colorectal Cancer (SIT) Receives: Diagnostic Test: Mobio PowerSoil DNA Isolation Kit | |
| NYU | New York University (NYU) Human Microbiome and Colorectal Tumor study Receives: Diagnostic Test: Mobio PowerSoil DNA Isolation Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and relative abundance of selected fecal microbial taxa
Quantitative polymerase chain reaction
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start23 Nov 2011
- Primary completion25 Apr 2015
- Study completion25 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serrated PolypStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiyoung Ahn, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297996
- Sponsor's protocol ID
- 11-01377
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03297996
- Acronym / sponsor ID
- 11-01377
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 23 Nov 2011 (actual)
- Primary completion
- 25 Apr 2015 (actual)
- Study completion
- 25 Apr 2015 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIT | – | Diagnostic Test: Mobio PowerSoil DNA Isolation KitCenters for Disease Control and Prevention (CDC) Study of In-home Tests for Colorectal Cancer (SIT) |
| NYU | – | Diagnostic Test: Mobio PowerSoil DNA Isolation KitNew York University (NYU) Human Microbiome and Colorectal Tumor study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobio PowerSoil DNA Isolation Kit16S 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 | Diagnostic test | NYU, SIT |
Primary outcome
Prevalence and relative abundance of selected fecal microbial taxa
Time frame: 2 Days
Quantitative polymerase chain reaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiyoung Ahn, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serrated Polyp and Hyperplastic Polyp, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and relative abundance of selected fecal microbial taxa (time frame: 2 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.