Recruiting

Multi-Targeted Combined Detection Model for Gastrointestinal Cancer Screening

Study Aim

This study aims to compare cancer-specific mortality rates across the entire gastrointestinal tract between two groups, using a multi-targeted combined detection model for gastrointestinal cancer screening.

What is being tested

Multi-target blood methylation + fecal FIT + fecal calprotectin

Diagnostic Test

Who is being recruted

Digestive System Diseases+1

+ Neoplasms

+ Neoplasms by Site

From 45 to 74 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Screening Study

Interventional

Study Start: June 2026

See protocol details

Summary

Principal SponsorXijing Hospital

Study ContactYongzhan NieMore contacts

Last updated: July 17, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 15, 2026

Actual date on which the first participant was enrolled.

This study focuses on gastrointestinal cancer screening. It aims to enroll participants and divide them into two groups. The first group will be tested using a combined method of 'multi-target blood methylation + fecal FIT + fecal calpetin'. If the results are positive, they will immediately undergo a standard gastrointestinal endoscopy. If negative, they will be routinely observed. The second group will only receive routine observation and follow-up. The study's main goal is to evaluate if this active screening strategy can effectively reduce gastrointestinal cancer deaths compared to routine surveillance. This research hopes to provide strong evidence for a new screening strategy that could lessen the impact of gastrointestinal cancers and bring public health benefits, particularly in China.

NCT07712107

Principal SponsorXijing Hospital

Study ContactYongzhan NieMore contacts

Last updated: July 17, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

10000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 45 to 74 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesNeoplasmsNeoplasms by SiteDigestive System Neoplasms

Criteria

1 inclusion criteria required to participate

1\) Participants must be between 45 and 74 years of age at the time of enrollment; 2) Participants must agree to be randomly assigned to different screening and follow-up strategies; 3) Participants must agree to undergo a five-year follow-up in accordance with the protocol; 4) Participants must be willing to participate and sign an informed consent form

1 exclusion criteria prevent from participating

1\) Underwent upper gastrointestinal endoscopy screening within the past year; 2) History of any type of malignant tumor; 3) Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders; 4) Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy); 5) Pregnant or breastfeeding women

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

No Intervention

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Recruiting

Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province

Zhaoqing, ChinaOpen Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province in Google Maps

Recruiting

The 960th Hospital of the Joint Support Force of the People's Liberation Army of China

Jinan, China

Recruiting

Yanting County Tumor Hospital

Mianyang, China

Recruiting

Wuwei Cancer Hospital of Gansu Province

Wuwei, China

Recruiting

6 Study Centers