Lifestyle and Dietary Pattern in Relation to Precursor Le... | NCT03708952

Studies
Lifestyle and Dietary Pattern in Relation to Precursor Lesions of Colorectal Cancer and Cardiometabolic Diseases

NCT03708952

Sponsor

Zhejiang University

Status

Active, not recruiting

Last Update Posted

Jan 10, 2024Actual

Enrollment

25,000Estimated

Phase

Not provided

Conditions

Polyps
Cardiovascular Diseases

Interventions

Not provided

Countries

China

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

May 1, 2028Estimated

First Submitted Date

Oct 14, 2018

First Submission Date that Met QC Criteria

Oct 14, 2018

First Posted Date

Oct 17, 2018Actual

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

Jan 7, 2024

Last Update Posted Date

Jan 10, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jingjing Jiao, Associate Professor, Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Zhejiang UniversityOTHER

Collaborators

Name	Class
Lanxi Hospital of Traditional Chinese Medicine	OTHER
Lanxi Red Cross Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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.

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

25,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numbers of participants with polyps	All polyps	From entry into the study (baseline:2018-2022) until 2028

Secondary Outcomes

Measure	Description	Time Frame
Numbers of participants with different subtypes of polyps	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

Other Outcomes

Measure	Description	Time Frame
Numbers of participants died	All-cause and cause-specific mortality outcomes	From entry into the study (baseline:2018-2022) until 2028

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects are eligible residents from 16 towns and villages of Jinhua, China.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Weifang Zheng, MD	Lanxi Red Cross Hospital	Principal Investigator
Jingjing Jiao	Zhejiang University	Principal Investigator
Pan Zhuang	Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lanxi Hospital of Traditional Chinese Medicine		Jinhua	Zhejiang	321000	China
Lanxi Red Cross Hospital

Condition Browse Module

MeSH Terms

ID	Term
D011127	Polyps
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided