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

NCT06118437 | Recruiting

• 1 other identifier: XJLL-KY-20232231
• Study Type: observational
• Target: 1,550
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Tumor of Digestive Tract; Risk Factors

Outcome Measures

Primary Outcomes (1)

• Overall detection rate of gastrointestinal cancer

  The proportion of at least one type of gastrointestinal malignant tumor detected

  2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Continuous patients who underwent both gastroscopy and colonoscopy at the digestive endoscopy center from October 2023 to May 2025

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing of Digestive Diseases

Xi'an, Shaanxi, China

RECRUITING

Related Publications (2)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Klein EA, Richards D, Cohn A, Tummala M, Lapham R, Cosgrove D, Chung G, Clement J, Gao J, Hunkapiller N, Jamshidi A, Kurtzman KN, Seiden MV, Swanton C, Liu MC. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-1177. doi: 10.1016/j.annonc.2021.05.806. Epub 2021 Jun 24.

  PMID: 34176681 BACKGROUND

Central Study Contacts

Yang lin Pan, MD

CONTACT

862984771536; yanglinpan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: July 15, 2023
• Primary Completion: April 30, 2025
• Study Completion: July 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2024-07

Locations

CN (1)