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

Not yet 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

• Status Verified: 2023-11
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Study Start: 2023-11-15
• Primary Completion: 2024-12-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6250

Inclusion Criteria

• Individuals aged 18-80 who undergo both gastroscopy and colonoscopy simultaneously

Exclusion Criteria

• （1）Previously diagnosed with esophageal, gastric, or colorectal cancer; (2) Suspected presence of gastrointestinal obstruction or perforation; (3) Previous history of esophageal, gastric, or colorectal surgery; (4) Those who are not suitable for endoscopic examination due to serious diseases or unstable hemodynamics; (5) Individuals who are unable to obtain relevant information due to communication barriers such as mental or neurological disorders; (6) Pregnancy or lactation period; (7) Not willing or unable to sign the 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