Combined Screening for Gastrointestinal Tumors

NCT ID: NCT06478030

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2028-12-31

Brief Summary

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All participants are required to complete a questionnaire, a Helicobacter pylori (H. pylori) test, and a fecal immunochemical test (FIT). The questionnaire covers nine aspects: basic information of the participants, symptoms and previous examinations, medical history and surgical history, medication history, smoking history, alcohol consumption history, dietary habits, physical exercise, and family history. After quality control, the data is entered by staff into the Zhejiang Province Cancer Screening Information Platform. Risk assessments are performed based on the data collected and high-risk individuals are recommended for clinical screening. Additionally, tongue image, stool, urine, blood, tongue coating, saliva, gastric juice, and fresh tissue (gastric mucosa tissue and/or intestinal polyp tissue) samples are collected from all participants undergoing clinical screening.

Participants are required to complete at least one passive follow-up annually. Active follow-ups are conducted for those with positive screening results to ensure timely completion of endoscopic examinations. For those who have not undergone endoscopic examinations despite positive screening results, health education is provided, and they are mobilized at least four times within one month to complete endoscopic examinations. For participants diagnosed and treated for precancerous lesions and tumors, diagnostic and treatment data must be collected, and they are encouraged to follow up as per medical advice. Both active and passive follow-up results must be recorded in the screening follow-up information record form and reported to the Zhejiang Province Cancer Screening Information Platform.

This is a government collaboration project. All subjects will also be followed by record linkage to Cancer Register and Population Register.

Detailed Description

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Conditions

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Gastrointestinal Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Screening cohort

Healthy participants aged 40-74 years from designated communities.

questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT)

Intervention Type DIAGNOSTIC_TEST

The questionnaire covers nine aspects: basic information of the participants, symptoms and previous examinations, medical history and surgical history, medication history, smoking history, alcohol consumption history, dietary habits, physical exercise, and family history.

Interventions

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questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT)

The questionnaire covers nine aspects: basic information of the participants, symptoms and previous examinations, medical history and surgical history, medication history, smoking history, alcohol consumption history, dietary habits, physical exercise, and family history.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Subject residents from Zhejiang Province.
* Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
* Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.

Exclusion Criteria

* Subject has heavy cardiovascular, liver or kidney disease.
* Subject is already suffering from malignant tumors of the digestive tract.
* Subject has severe intellectual disabilities or language communication barriers.
* Subject has had gastrointestinal endoscopy in the past year.
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fenghua District People's Hospital, Ningbo City

UNKNOWN

Sponsor Role collaborator

Fenghua District Traditional Chinese Medicine Hospital, Ningbo City

UNKNOWN

Sponsor Role collaborator

Xikou Hospital in Fenghua District, Ningbo City

UNKNOWN

Sponsor Role collaborator

Yongkang Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Hangzhou Medical College

OTHER

Sponsor Role collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiangdong Cheng

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yongkang City

Jinhua, Zhejiang, China

Site Status RECRUITING

Fenghua District

Ningbo, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangdong Cheng, MD

Role: CONTACT

13968032995

Facility Contacts

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Lingbin Du

Role: primary

+86-13588114180

Xiangdong Cheng, MD

Role: primary

13968032995

Other Identifiers

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IRB-2023-890

Identifier Type: -

Identifier Source: org_study_id

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