A Population-based, Multicenter Cohort Study of Combined Screening for Gastrointestinal Tumors

October 9, 2023 updated by: Xijing Hospital
To establish combined gastroenteroscopy screening and follow-up management for gastrointestinal tumors, explore and evaluate the feasibility and health economic benefits of combined screening for esophagus, stomach and colorectal cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

group one: The screening population will undergo gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori (HP) antigen test, ring finger protein 180 (RNF180) and SEPTIN9 gene methylation test, and investigation of risk factors, including past disease history, alcohol drinking history, smoking history, tea drinking history, family history of cancer, marital and reproductive status, and dietary habits.

group two: The screening population will undergo investigation of risk factors, a fecal occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a stool occult blood test or H. pylori antigen is positive after testing, RNF180 and SEPTIN9 gene methylation testing will be scheduled. If the gene methylation test is positive, a colonoscopy will be scheduled.

Group one's control（Spouse or sibling of group one);group two's control（Spouse or sibling of group one): Only the risk factors will be investigated, including previous disease history, drinking history, smoking history, drinking history, family history of malignant tumor, marriage and childbearing status, eating habits, etc.

Finally, 10 years follow-up will be conducted to observe the outcome

Study Type

Observational

Enrollment (Estimated)

84000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangzhou
      • Zhaoqing, Guangzhou, China, 526040
        • Recruiting
        • Gaoyao District People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Eligible Chinese persons

Description

Inclusion Criteria:

  • 1. Subjects were 45 to 70 years old when enrolled 2. Willing and able to sign informed consent

Exclusion Criteria:

  • 1. History of any type of malignancy 2. Previous resection of esophagus, stomach or colorectal 3. Received gastrointestinal endoscopy such as colonoscopy and gastroscopy in recent 5 years 4. Have received fecal occult blood test and fecal DNA test in the past 1 year. 5. Contraindications to endoscopy. 6. Warning symptoms of digestive tract tumors, including:

    1. Difficulty swallowing, choking or halting feeling when eating recently
    2. Recent esophageal foreign body sensation or swallowing pain
    3. Recent long-term loss of appetite and appetite
    4. Recent and prolonged symptoms of indigestion (including acid reflux, heartburn, abdominal grumbling, burping, nausea or premature satiety, etc.)
    5. Recent symptoms of abdominal mass, abdominal pain, vomiting or hematemesis
    6. It was medically diagnosed as iron deficiency anemia
    7. Recent changes in hematochezia, black stool or stool character and frequency
    8. Recent symptoms of perianal discomfort (including soreness, itching, lumps, prolapse or other discomfort)
    9. Unexplained weight loss (more than 10% of base body weight) in the past 6 months Step 7 Get pregnant 8. There are other serious comorbiditions that reduce screening benefits (including severe lung disease, advanced kidney disease, advanced liver disease, severe heart failure, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group one
The screening population will undergo gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori (HP) antigen test, ring finger protein 180 (RNF180) and SEPTIN9 gene methylation test, and investigation of risk factors, including past disease history, alcohol drinking history, smoking history, tea drinking history, family history of cancer, marital and reproductive status, and dietary habits.
Other: Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test
group one: The screening population will undergo gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori (HP) antigen test, RNF180/Septin9 gene methylation test, and investigation of risk factors, including past disease history, alcohol drinking history, smoking history, tea drinking history, family history of cancer, marital and reproductive status, and dietary habits.
Other: Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test
group two: The screening population will undergo investigation of risk factors, a fecal occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a stool occult blood test or H. pylori antigen is positive after testing, RNF180 and SEPTIN9 gene methylation testing will be scheduled. If the gene methylation test is positive, a colonoscopy will be scheduled.
Group one's control（Spouse or sibling of group one )
Only the risk factors will be investigated
Other: Risk factor investigation;
Only the risk factors will be investigated, including previous disease history, drinking history, smoking history, drinking history, family history of malignant tumor, marriage and childbearing status, eating habits, etc.
group two
The screening population will undergo investigation of risk factors, a fecal occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a stool occult blood test or H. pylori antigen is positive after testing, RNF180 and SEPTIN9 gene methylation testing will be scheduled. If the gene methylation test is positive, a colonoscopy will be scheduled.
Other: Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test
group one: The screening population will undergo gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori (HP) antigen test, RNF180/Septin9 gene methylation test, and investigation of risk factors, including past disease history, alcohol drinking history, smoking history, tea drinking history, family history of cancer, marital and reproductive status, and dietary habits.
Other: Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test
group two: The screening population will undergo investigation of risk factors, a fecal occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a stool occult blood test or H. pylori antigen is positive after testing, RNF180 and SEPTIN9 gene methylation testing will be scheduled. If the gene methylation test is positive, a colonoscopy will be scheduled.
group two's control（Spouse or sibling of group two)
Only the risk factors will be investigated
Other: Risk factor investigation;
Only the risk factors will be investigated, including previous disease history, drinking history, smoking history, drinking history, family history of malignant tumor, marriage and childbearing status, eating habits, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer or precancerous lesions detected
Time Frame: 10 year
Cancer or precancerous lesions detected
10 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Kaichun Wu, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

November 30, 2032

Study Completion (Estimated)

June 30, 2033

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232111-F-1号

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

According to the research process, choose a specific method to disclose the original data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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