PolypsNCT03708952
Lifestyle and Dietary Pattern in Relation to Precursor Lesions of Colorectal Cancer and Cardiometabolic Diseases
An observational study of Polyps and Cardiovascular Diseases, run by Zhejiang University at 2 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyps, Cardiovascular Diseases
- How many people
- 25,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2018to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects are eligible residents from 16 towns and villages of Jinhua, China.
Who may be able to join
- Subject aged ≥45 and ≤74 years old
- Subject has complete data on diet and follow-up time
Who cannot join
- Colorectal cancer
- Severe intestines problems
Trial locations and contacts
2 sites in 1 country.
China2 sites
Lanxi Hospital of Traditional Chinese Medicine
Jinhua, Zhejiang, 321000
Lanxi Red Cross Hospital
Lanxi, Zhejiang, 321100
About this study
Official title: 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.
Read the 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.
- Conditions
- Polyps, Cardiovascular Diseases
- Keywords
- Dietary factors, Precursor lesions of colorectal cancer, Lifestyle, Polyps, Cardiovascular Diseases
- Medical subject headings
- Polyps, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participants with polyps
All polyps
Measured: From entry into the study (baseline:2018-2022) until 2028
Secondary outcomes (2)
Numbers of participants with different subtypes of polyps
Subtypes of polyps, including serrated polyps, hyperplastic polyps, sessile serrated polyps/adenoma
Measured: From entry into the study (baseline:2018-2022) until 2028
Numbers of participants with cardiometabolic diseases
Cardiometabolic diseases including cardiovascular disease, diabetes, and hypertension
Measured: From entry into the study (baseline:2018-2022) until 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 May 2018
- Primary completion1 Dec 2024 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypsStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Lanxi Hospital of Traditional Chinese Medicine, Lanxi Red Cross Hospital
- Responsible party
- Principal investigator, Jingjing Jiao, Zhejiang University
- Investigators
- Weifang Zheng, MD, Principal investigator, Lanxi Red Cross HospitalJingjing Jiao, Principal investigator, Zhejiang UniversityPan Zhuang, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708952
- Sponsor's protocol ID
- cohort- colorectal cancer
- Status last verified
- Jan 2024
- First submitted
- 14 Oct 2018
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle and Dietary Pattern in Relation to Precursor Lesions of Colorectal Cancer and Cardiometabolic Diseases Among High-risk Populations in Lanxi, China
- ClinicalTrials.gov ID
- NCT03708952
- Acronym / sponsor ID
- cohort- colorectal cancer
- Conditions
- Polyps, Cardiovascular Diseases
- Keywords
- Dietary factors, Precursor lesions of colorectal cancer, Lifestyle, Polyps, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Lanxi Hospital of Traditional Chinese Medicine, Lanxi Red Cross Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 17 Oct 2018 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are eligible residents from 16 towns and villages of Jinhua, China.
Key inclusion criteria (2 listed)
- Subject aged ≥45 and ≤74 years old
- Subject has complete data on diet and follow-up time
Key exclusion criteria (2 listed)
- Colorectal cancer
- Severe intestines problems
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
Numbers of participants with polyps
Time frame: From entry into the study (baseline:2018-2022) until 2028
All polyps
2 secondary outcomes
Numbers of participants with different subtypes of polyps
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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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.
Weifang Zheng, MD principal investigator
Lanxi Red Cross Hospital
Jingjing Jiao principal investigator
Zhejiang University
Pan Zhuang principal investigator
Zhejiang University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyps and Cardiovascular Diseases, run by Zhejiang University at 2 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Numbers of participants with polyps (time frame: From entry into the study (baseline:2018-2022) until 2028). 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 10 Jan 2024.