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Recruiting

NCT Number: NCT06478030

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.

Recruiting

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Key information

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongkang City, Jinhua, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Gastrointestinal cancers detection, incidence and mortality

    Time frame: 5 years

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

Secondary outcomes

  1. Early diagnosis of gastrointestinal cancers

    Time frame: 5 years

    Early diagnosis of gastrointestinal cancers using different strategies.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangdong Cheng, MD

CONTACT

[email protected]

13968032995

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Collaborators

  • Fenghua District People's Hospital, Ningbo City
  • Fenghua District Traditional Chinese Medicine Hospital, Ningbo City
  • Hangzhou Medical College
  • Xikou Hospital in Fenghua District, Ningbo City
  • Yongkang Traditional Chinese Medicine Hospital

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 27, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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