Combined Screening for Gastrointestinal Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Tumors
• Intervention / Treatment: Diagnostic test: questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT)

• Study Type: Observational
• Enrollment (Estimated): 200000

Contacts and Locations

• Study Contact: Name: Xiangdong Cheng, MD; Phone Number: 13968032995; Email: chengxd@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Jinhua, Zhejiang, China, 321300
      • Recruiting
      • Yongkang City
      • Contact: Lingbin Du; Phone Number: +86-13588114180; Email: dulb@zjcc.org.cn
    • Ningbo, Zhejiang, China, 315500
      • Recruiting
      • Fenghua District
      • Contact: Xiangdong Cheng, MD; Phone Number: 13968032995; Email: chengxd@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Population data obtained from local government departments is used to identify eligible participants. From this pool, individuals who meet the criteria are selected, and their names along with basic information are recorded.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Screening cohort; Healthy participants aged 40-74 years from designated communities.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal cancers detection, incidence and mortality	Gastrointestinal cancers detection through endoscopies, and gastrointestinal cancers incidence and mortality with long-term follow-up.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early diagnosis of gastrointestinal cancers	Early diagnosis of gastrointestinal cancers using different strategies.	5 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Collaborators: Yongkang Traditional Chinese Medicine Hospital; Yongkang First People's Hospital; Fenghua District People's Hospital, Ningbo City; Fenghua District Traditional Chinese Medicine Hospital, Ningbo City; Xikou Hospital in Fenghua District, Ningbo City

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: IRB-2023-890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not provided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No