Early Screening Cohort Study of Multiple Gastrointestinal Tumors

NCT07106424 · tracked via the Priya Life Science China tracker

Sponsor

Shandong Cancer Hospital and Institute

Phase

Observational

Started

2024-09-10

Last updated

2025-08-06

Condition(s) studied

Early Detection of Cancer

Study summary

Gastrointestinal tumors, including esophageal cancer, gastric cancer, and colorectal cancer, are among the most common and highly prevalent malignant tumors in Shandong Province. Currently, most patients seek medical attention only after clinical symptoms appear, by which time the disease has already reached an intermediate or advanced stage. This leads to increased treatment costs and poorer therapeutic outcomes. Early detection and intervention through screening are effective measures to improve the cure rate of gastrointestinal tumors and reduce their incidence and mortality rates.

This project leverages the Shandong Province Tumor Screening and Early Diagnosis \& Treatment Platform and is based on the ongoing Shandong Gastrointestinal Cancer Screening Cohort. It aims to collect 4,000 plasma samples from individuals undergoing simultaneous screening for esophageal, gastric, and colorectal cancers. Using Nanjing Shihe Medical Laboratory's independently developed multi-cancer early detection liquid biopsy product for gastrointestinal cancers, the study will further validate the performance of liquid biopsy in multi-cancer screening by correlating results with endoscopic findings (gastroscopy and colonoscopy).

Eligibility

Sex

ALL

Min age

40 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * gastrointestinal cancer screening population * age 40-75 * no prior history of tumors Exclusion Criteria: * Severe heart disease, heart failure; * Severe respiratory disease, dyspnea, continuous asthma, or those with serious brain diseases; * Severe spinal deformity, or patients with aneurysms; * Physically weak and unable to tolerate endoscopy, or those who have difficulty remaining calm and self-controlled; * Acute corrosive inflammation of the gastrointestinal tract, or those suspected of having a gastrointestinal perforation; * Large amounts of ascites, severe abdominal distension, or severe esophageal varices; * Those with a tendency to bleed (abnormal coagulation function), or those taking anticoagulant medications. The latter must discontinue the medication for one week and have normal coagulation function before undergoing endoscopy; * Pregnant women; * Those with a history of iodine allergy, etc. * Patients who have been diagnosed with tumors or have a history of prior tumors.

Primary outcome measure(s)

Sensitivity for detection of high-grade (or above) gastric/esophageal/colorectal cancer — 2024.7-2027.7
Primary Objective: Sensitivity for detecting high-grade or above gastric/esophageal/colorectal lesions. Secondary Objectives: Positive predictive value (PPV), specificity, and negative predictive value (NPV) for detecting high-grade or above gastric/esophageal/colorectal lesions. PPV and sensitivity for detecting other cancer types.

Trial sites (1)

Facility	City	Region	Status
Affiliated Cancer Hospital of Shandong First Medical University	Jinan	Shandong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07106424 on ClinicalTrials.gov ↗ ← All trials in China