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

November 1, 2023 updated by: Yanglin Pan, Air Force Military Medical University, China

Establishment and Validation of a Clinical Predictive Model for Gastrointestinal Cancer Screening Based on Patient-related Risk Factors: a Prospective, Multicenter Cross-sectional Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

6250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Xijing of Digestive Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall detection rate of gastrointestinal cancer
Time Frame: 2 years
The proportion of at least one type of gastrointestinal malignant tumor detected
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJLL-KY-20232231

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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