Combined Screening for Gastrointestinal Tumors

NCT06478030 | Recruiting

• 1 other identifier: IRB-2023-890
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastrointestinal Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Early diagnosis of gastrointestinal cancers

  5 years

Study Arms (1)

Screening cohort

Healthy participants aged 40-74 years from designated communities.

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

Interventions

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

Screening cohort

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• Fenghua District People's Hospital, Ningbo City: collaborator
• Fenghua District Traditional Chinese Medicine Hospital, Ningbo City: collaborator
• Xikou Hospital in Fenghua District, Ningbo City: collaborator
• Yongkang Traditional Chinese Medicine Hospital: collaborator
• Hangzhou Medical College: collaborator

Study Sites (2)

Yongkang City

Jinhua, Zhejiang, 321300, China

RECRUITING

Fenghua District

Ningbo, Zhejiang, 315500, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

stool, urine, blood, tongue coating, saliva, gastric juice, and fresh tissue (gastric mucosa tissue and/or intestinal polyp tissue).

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Central Study Contacts

Xiangdong Cheng, MD

CONTACT

13968032995; chengxd@zjcc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)