Clinical trial NCT06478030: Combined Screening for Gastrointestinal Tumors
Official title: Combined Screening for Gastrointestinal Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Tumors
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Fenghua District People's Hospital, Ningbo City
name: Fenghua District Traditional Chinese Medicine Hospital, Ningbo City
name: Xikou Hospital in Fenghua District, Ningbo City
name: Yongkang Traditional Chinese Medicine Hospital
name: Hangzhou Medical College
First posted: 2024-06-27
Enrollment: 200000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gastrointestinal cancers detection, incidence and mortality
timeFrame: 5 years
Secondary outcomes:
measure: Early diagnosis of gastrointestinal cancers
timeFrame: 5 years
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Yongkang City
state: Zhejiang
city: Ningbo
country: China
facility: Fenghua District
state: Zhejiang
Study officials:
References: