Establishment and Validation of a Clinical Predictive Model for Gastrointestinal Cancer Screening Based on Patient-related Risk Factors

Recruiting

• Conditions: Malignant Tumor of Digestive Tract; Risk Factors

• Registration Number: NCT06118437
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

Gastrointestinal tumors (esophageal cancer, gastric cancer, colorectal cancer) seriously threaten human health, with a high incidence rate and cancer related hope mortality. Digestive endoscopy is the main method for screening gastrointestinal tumors. Early screening of gastrointestinal tumors can improve the detection of early cancer and improve prognosis. The five-year survival rate of early stage tumors after comprehensive treatment can reach 90%, while the five-year survival rate of late stage tumors is less than 30%. Therefore, the screening of gastrointestinal tumors is very important.

Studies have shown that there are similarities in risk factors for gastrointestinal tumors, such as age, gender, family history, smoking, alcohol consumption, etc. Currently, established digestive malignancies are targeted at a single malignant tumor. At present, there is a lack of understanding of the overall risk factors associated with gastrointestinal tumors and the establishment of relevant risk prediction models.

Therefore, we conducted a prospective, multicenter cross-sectional study to explore the independent risk factors of combined gastrointestinal tumors and establish a risk prediction model for combined screening of gastrointestinal tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-15
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Status Verified: 2024-07
• Primary Completion: 2025-04-30
• Study Completion: 2025-07-01
• Last Update Submitted: 2025-07-23
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1550

Inclusion Criteria

• Individuals aged 18-80;
• Undergoing both gastroscopy and colonoscopy simultaneously.

Exclusion Criteria

• History of esophageal, gastric, or colorectal cancer;
• Suspicions of gastrointestinal obstruction or perforation;
• History of gastrointestinal tract surgery;
• Not suitable for endoscopic examination due to serious diseases or unstable hemodynamics;
• Unavailable relevant information;
• Pregnancy or lactation period;
• Unavailable informed consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall detection rate of gastrointestinal cancer	2 years	The proportion of at least one type of gastrointestinal malignant tumor detected

Trial Locations

Locations (1)

Xijing of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China