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RecruitingNCT06478030Updated Jan 28, 2025

Combined Screening for Gastrointestinal Tumors

An observational study in Gastrointestinal Tumors, sponsored by Zhejiang Cancer Hospital. Recruiting at 2 sites in China. Open to participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by Zhejiang Cancer Hospital · Observational

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200,000
Ages
40 Years to 74 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastrointestinal Tumors
03

In context

Digestive System Neoplasms

311 studies on the registry are indexed under Digestive System Neoplasms; 83 are open to participants now.

This study's planned enrollment of 200,000 is above the median of 196 across 68 observational studies indexed under Digestive System Neoplasms.

Browse Digestive System Neoplasms studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Screening cohort

    Healthy participants aged 40-74 years from designated communities.

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

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.

06

What researchers measure

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.

    Time frame: 5 years

Secondary outcomes

  1. Early diagnosis of gastrointestinal cancers

    Early diagnosis of gastrointestinal cancers using different strategies.

    Time frame: 5 years

07

Study locations

2 of 2 sites recruiting
  • Yongkang City
    Jinhua, Zhejiang 321300, China
    Recruiting
  • Fenghua District
    Ningbo, Zhejiang 315500, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Not provided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06478030
Lead sponsor
Zhejiang Cancer Hospital
Collaborators
Fenghua District People's Hospital, Ningbo City, Fenghua District Traditional Chinese Medicine Hospital, Ningbo City, Xikou Hospital in Fenghua District, Ningbo City, Yongkang Traditional Chinese Medicine Hospital, Yongkang First People's Hospital
Responsible party
Xiangdong Cheng (Chief physician, Zhejiang Cancer Hospital) — Principal investigator
First posted
Jun 27, 2024
Start date
Mar 1, 2023
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 28, 2025

Study contacts

Xiangdong Cheng, MD
Contact
chengxd@zjcc.org.cn
13968032995

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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