Combined Screening for Gastrointestinal Tumors

Recruiting

• Conditions: Gastrointestinal Tumors
• Interventions: Diagnostic Test: questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT)

• Registration Number: NCT06478030
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-28
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening cohort	questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT)	Healthy participants aged 40-74 years from Fenghua District, Ningbo City.

Primary Outcome Measures

Name	Time	Method
Gastrointestinal cancers detection, incidence and mortality	5 years	Gastrointestinal cancers detection through endoscopies, and gastrointestinal cancers incidence and mortality with long-term follow-up.

Secondary Outcome Measures

Name	Time	Method
Early diagnosis of gastrointestinal cancers	5 years	Early diagnosis of gastrointestinal cancers using different strategies.

Trial Locations

Locations (2)

Yongkang City; 🇨🇳 Jinhua, Zhejiang, China

Fenghua District; 🇨🇳 Ningbo, Zhejiang, China