Early Screening Cohort Study of Multiple Gastrointestinal Tumors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorShandong Cancer Hospital and Institute

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

4,000 Participants
are grouped into 1 trial group
Group A: gastrointestinal tumor screening

Trial outcomes

Primary outcomes

1

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.

Time frame
2024.7-2027.7

Secondary outcomes

Other outcomes

Sponsors and contacts

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