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Combined Screening for Gastrointestinal Tumors

Combined Screening for Gastrointestinal Tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06478030
Enrollment
200000
Registered
2024-06-27
Start date
2023-03-01
Completion date
2028-12-31
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Tumors

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.

Interventions

DIAGNOSTIC_TESTquestionnaire, 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.

Sponsors

Fenghua District People's Hospital, Ningbo City
CollaboratorUNKNOWN
Fenghua District Traditional Chinese Medicine Hospital, Ningbo City
CollaboratorUNKNOWN
Xikou Hospital in Fenghua District, Ningbo City
CollaboratorUNKNOWN
Yongkang Traditional Chinese Medicine Hospital
CollaboratorUNKNOWN
Hangzhou Medical College
CollaboratorOTHER
Zhejiang Cancer Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gastrointestinal cancers detection, incidence and mortality5 yearsGastrointestinal cancers detection through endoscopies, and gastrointestinal cancers incidence and mortality with long-term follow-up.

Secondary

MeasureTime frameDescription
Early diagnosis of gastrointestinal cancers5 yearsEarly diagnosis of gastrointestinal cancers using different strategies.

Countries

China

Contacts

Primary ContactXiangdong Cheng, MD
chengxd@zjcc.org.cn13968032995

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026