About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
gastrointestinal cancer screening population
age 40-75
no prior history of tumors
Disqualifiers
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;
Trial population
Individuals undergoing screening for esophageal cancer, gastric cancer, and colorectal cancer within the Shandong Province gastrointestinal screening cohort aged 40-74 years.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Sensitivity for detection of high-grade (or above) gastric/esophageal/colorectal cancer
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.
Sponsors and contacts
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