Combined Screening for Gastrointestinal Tumors

Обзор

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Gastrointestinal cancers detection, incidence and mortality [Срок оценки: 5 years]

Вторичные конечные точки (1)

• Early diagnosis of gastrointestinal cancers [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Yongkang City — Jinhua
• Fenghua District — Ningbo

Идентификаторы

NCT: NCT06478030 · IRB-2023-890

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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