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

NCT05996458 | Recruiting

• 1 other identifier: KY20232111-F-1号
• Study Type: observational
• Target: 84,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Digestive Disease

Outcome Measures

Primary Outcomes (1)

• Cancer or precancerous lesions detected

  Cancer or precancerous lesions detected

  10 year

Study Arms (4)

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's control（Spouse or sibling of group one )

Only the risk factors will be investigated

Other: Risk factor investigation;

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 two's control（Spouse or sibling of group two)

Only the risk factors will be investigated

Other: Risk factor investigation;

Interventions

Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test OTHER

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.

group one

Risk factor investigation; OTHER

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 one's control（Spouse or sibling of group one ); group two's control（Spouse or sibling of group two)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible Chinese persons

You may qualify if:

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

You may not qualify if:

• \. 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:
• Difficulty swallowing, choking or halting feeling when eating recently
• Recent esophageal foreign body sensation or swallowing pain
• Recent long-term loss of appetite and appetite
• Recent and prolonged symptoms of indigestion (including acid reflux, heartburn, abdominal grumbling, burping, nausea or premature satiety, etc.)
• Recent symptoms of abdominal mass, abdominal pain, vomiting or hematemesis
• It was medically diagnosed as iron deficiency anemia
• Recent changes in hematochezia, black stool or stool character and frequency
• Recent symptoms of perianal discomfort (including soreness, itching, lumps, prolapse or other discomfort)
• 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.)

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Gaoyao District People's Hospital

Zhaoqing, Guangzhou, 526040, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood；tissue

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

• Kaichun Wu

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

rong zheng

CONTACT

19829758242; zhengrong4956@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): November 30, 2032
• Study Completion (Estimated): June 30, 2033
• Last Updated: October 11, 2023

Record last verified: 2023-07

Locations

CN (1)