Colorectal PolypNCT04684134
High-Risk Factors in Patients With Colorectal Polyps a Prospective Case-Control Study
An observational study of Colorectal Polyp, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This prospective case-control study aimed to analyze and summarize the high-risk factors and susceptible genes of patients with colorectal polyps. According to these high-risk factors, the investigators developed and validated a prediction model for colorectal polyps to identify high-risk individuals, in order to… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp
- How many people
- 2,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Jun 2020
- How long will I take part?
- 1 Year
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 2800 confirmed eligible participants, 18 to 80 years of age, including 2000 cases with colorectal polyps and 800 controls free of colorectal polyps, are enrolled in this study.
Who may be able to join
- Subject aged ≥18 and ≤80 years old. Subject with complete data on demography and clinicopathology.
Who cannot join
- Subject with inflammatory bowel disease, enterophthisis, familial adenomatous polyposis, P-J syndrome and intestinal lymphoma.
- A history of severe systemic diseases: liver cirrhosis, metabolic syndrome, chronic kidney disease, malignancy.
- Subject taking blood lipid-lowering drugs, hormone or immunosuppressive agents. Unwillingness to cooperate with questionnaire survey. Lack of complete clinical data for analysis.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
This prospective case-control study aimed to analyze and summarize the high-risk factors and susceptible genes of patients with colorectal polyps. According to these high-risk factors, the investigators developed and validated a prediction model for colorectal polyps to identify high-risk individuals, in order to provide clinical basis for the etiology research and the establishment of effective preventive measures.
Read the detailed description
A large cohort of eligible participants were included in the analysis, and classified into derivation and validation cohorts at a ratio of 7:3. Demographic and clinicopathological characteristics of participants were utilized to develop a prediction model for colorectal polyps. In the derivation cohort, the LASSO regression method was applied to filter variables and select the most useful high-risk factors. Multivariate logistic regression analysis was used to identify potential predictors and then a prediction model was established. The predictive performance of the model was evaluated with respect to its discrimination, calibration and clinical usefulness.
- Conditions
- Colorectal Polyp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | patients with colorectal polyps | |
| control group | patients without intestinal diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and clinicopathological characteristics of participants with polyps
demographic and clinicopathological characteristics
Measured: 1 year
Secondary outcomes (1)
Independent high-risk factors of participants with polyps
high-risk factors
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jun 2019
- Primary completion1 May 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- 2,800 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684134
- Sponsor's protocol ID
- 2019-SR-020
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Oines M, Helsingen LM, Bretthauer M, Emilsson L. Epidemiology and risk factors of colorectal polyps. Best Pract Res Clin Gastroenterol. 2017 Aug;31(4):419-424. doi: 10.1016/j.bpg.2017.06.004. Epub 2017 Jun 28.
PubMed 28842051Bailie L, Loughrey MB, Coleman HG. Lifestyle Risk Factors for Serrated Colorectal Polyps: A Systematic Review and Meta-analysis. Gastroenterology. 2017 Jan;152(1):92-104. doi: 10.1053/j.gastro.2016.09.003. Epub 2016 Sep 14.
PubMed 27639804
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Risk Factors in Patients With Colorectal Polyps a Prospective Case-Control Study
- ClinicalTrials.gov ID
- NCT04684134
- Acronym / sponsor ID
- 2019-SR-020
- Conditions
- Colorectal Polyp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 24 Dec 2020 (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.
This prospective case-control study aimed to analyze and summarize the high-risk factors and susceptible genes of patients with colorectal polyps. According to these high-risk factors, the investigators developed and validated a prediction model for colorectal polyps to identify high-risk individuals, in order to provide clinical basis for the etiology research and the establishment of effective preventive measures.
Detailed description
A large cohort of eligible participants were included in the analysis, and classified into derivation and validation cohorts at a ratio of 7:3. Demographic and clinicopathological characteristics of participants were utilized to develop a prediction model for colorectal polyps. In the derivation cohort, the LASSO regression method was applied to filter variables and select the most useful high-risk factors. Multivariate logistic regression analysis was used to identify potential predictors and then a prediction model was established. The predictive performance of the model was evaluated with respect to its discrimination, calibration and clinical usefulness.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –patients with colorectal polyps |
| control group | – | –patients without intestinal diseases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 2800 confirmed eligible participants, 18 to 80 years of age, including 2000 cases with colorectal polyps and 800 controls free of colorectal polyps, are enrolled in this study.
Key inclusion criteria (1 listed)
- Subject aged ≥18 and ≤80 years old. Subject with complete data on demography and clinicopathology.
Key exclusion criteria (3 listed)
- Subject with inflammatory bowel disease, enterophthisis, familial adenomatous polyposis, P-J syndrome and intestinal lymphoma.
- A history of severe systemic diseases: liver cirrhosis, metabolic syndrome, chronic kidney disease, malignancy.
- Subject taking blood lipid-lowering drugs, hormone or immunosuppressive agents. Unwillingness to cooperate with questionnaire survey. Lack of complete clinical data for analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic and clinicopathological characteristics of participants with polyps
Time frame: 1 year
demographic and clinicopathological characteristics
1 secondary outcome
Independent high-risk factors of participants with polyps
Time frame: 1 year
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 24 Dec 2020.
- Background: PubMed 28842051Oines M, Helsingen LM, Bretthauer M, Emilsson L. Epidemiology and risk factors of colorectal polyps. Best Pract Res Clin Gastroenterol. 2017 Aug;31(4):419-424. doi: 10.1016/j.bpg.2017.06.004. Epub 2017 Jun 28.
- Background: PubMed 27639804Bailie L, Loughrey MB, Coleman HG. Lifestyle Risk Factors for Serrated Colorectal Polyps: A Systematic Review and Meta-analysis. Gastroenterology. 2017 Jan;152(1):92-104. doi: 10.1053/j.gastro.2016.09.003. Epub 2016 Sep 14.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colorectal Polyp, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 1 inclusion and 3 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 24 Dec 2020. 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 China. 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?
Demographic and clinicopathological characteristics of participants with polyps (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04684134, which also lists 2 linked publications.
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 24 Dec 2020.