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The impact of sequential screening strategies based on multi-gene methylation markers on the detection of upper gastrointestinal cancer: A multicenter, open-label, non-inferiority, cluster randomized controlled study

The impact of sequential screening strategies based on multi-gene methylation markers on the detection of upper gastrointestinal cancer: A multicenter, open-label, non-inferiority, cluster randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104513
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Diseases

Interventions

Traditional endoscopic screening group:None

Sponsors

National Clinical Research Center for Digestive Diseases/The First Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 74 Years

Inclusion criteria

Inclusion criteria: At the time of enrollment, the subjects were aged between 45 and 74 years old and met any of the following criteria: 1. Long-term residence in areas with a high incidence of esophageal cancer or gastric cancer; 2.Hp infection 3. There is a history of esophageal cancer or gastric cancer among first-degree relatives; 4. Previous history of chronic atrophic gastritis, gastric ulcers, gastric polyps, postoperative residual stomach, hypertrophic gastritis, pernicious anemia and other pregastric cancer diseases; Or suffer from chronic esophagitis, Barrett's esophagus, esophageal diverticulum, achalasia of the cardia, reflux esophagitis, benign esophageal stenosis and other esophageal diseases; 5. There are poor dietary habits (such as high-salt, pickled, and hot food) or living habits (such as long-term smoking and heavy drinking).

Exclusion criteria

Exclusion criteria: 1. Undergo upper gastrointestinal endoscopy screening within 1.1 years; 2. The screening benefits are reduced due to severe diseases, such as severe lung diseases, kidney diseases, liver diseases, cardiovascular and cerebrovascular diseases, and blood diseases, etc. 3. Other doctors assessed that the patient was at excessive risk for endoscopic screening (such as unstable hemodynamics) or had no benefit (short expected lifespan); 4.Pregnant or lactating women; 5.Unable to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Gastroscopy;RNF180 gene methylation detection;

Secondary

MeasureTime frame
SEPT9 gene methylation detection;

Countries

China

Contacts

Public ContactYongzhan Nie

The First Affiliated Hospital of Air Force Military Medical University

zhengrong4956@163.com+86 198 2975 8242

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026