- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03708952
Lifestyle and Dietary Pattern in Relation to Precursor Lesions of Colorectal Cancer and Cardiometabolic Diseases
January 7, 2024 updated by: Jingjing Jiao, Zhejiang University
Lifestyle and Dietary Pattern in Relation to Precursor Lesions of Colorectal Cancer and Cardiometabolic Diseases Among High-risk Populations in Lanxi, China
The association between lifestyle and dietary patterns with precursor lesions of colorectal cancer and cardiometabolic diseases is still unclear.
This study is conducted in Jinhua, a city with a high prevalence of colorectal cancer in China, to assess the relationship between lifestyle and dietary factors with precursor lesions of colorectal cancer and cardiometabolic diseases.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Investigations of lifestyle and dietary factors in relation to precursor lesions of colorectal cancer and cardiometabolic diseases are limited in China.
The investigators aim to collect the basic characteristics of participants at baseline, including sex, age, smoking, exercise, marriage, education level, dietary factors and so on, to assess the associations between lifestyle and dietary factors with precursor lesions of colorectal cancer and cardiometabolic diseases.
This large cohort - the Lanxi Pre-colorectal Cancer Cohort (LP3C) also included several subcohorts consisting of patients with CVD, diabetes, hypertension, metabolic syndrome, obese/overweight or fatty liver disease.
Results from this study will be valuable for colorectal cancer and cardiometabolic disease prevention in China.
Study Type
Observational
Enrollment (Estimated)
25000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Jinhua, Zhejiang, China, 321000
- Lanxi Hospital of Traditional Chinese Medicine
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Lanxi, Zhejiang, China, 321100
- Lanxi Red Cross Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Subjects are eligible residents from 16 towns and villages of Jinhua, China.
Description
Inclusion Criteria:
- Subject aged ≥45 and ≤74 years old
- Subject has complete data on diet and follow-up time
Exclusion Criteria:
- Colorectal cancer
- Severe intestines problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numbers of participants with polyps
Time Frame: From entry into the study (baseline:2018-2022) until 2028
|
All polyps
|
From entry into the study (baseline:2018-2022) until 2028
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numbers of participants with different subtypes of polyps
Time Frame: From entry into the study (baseline:2018-2022) until 2028
|
Subtypes of polyps, including serrated polyps, hyperplastic polyps, sessile serrated polyps/adenoma
|
From entry into the study (baseline:2018-2022) until 2028
|
|
Numbers of participants with cardiometabolic diseases
Time Frame: From entry into the study (baseline:2018-2022) until 2028
|
Cardiometabolic diseases including cardiovascular disease, diabetes, and hypertension
|
From entry into the study (baseline:2018-2022) until 2028
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numbers of participants died
Time Frame: From entry into the study (baseline:2018-2022) until 2028
|
All-cause and cause-specific mortality outcomes
|
From entry into the study (baseline:2018-2022) until 2028
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jingjing Jiao, Zhejiang University
- Principal Investigator: Weifang Zheng, MD, Lanxi Red Cross Hospital
- Principal Investigator: Pan Zhuang, Zhejiang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
May 1, 2028
Study Registration Dates
First Submitted
October 14, 2018
First Submitted That Met QC Criteria
October 14, 2018
First Posted (Actual)
October 17, 2018
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 7, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- cohort- colorectal cancer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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