Early Screening Cohort Study of Multiple Gastrointestinal Tumors

Esophageal cancer, gastric cancer, and colorectal cancer are common gastrointestinal malignancies in China, accounting for 25.54% of all cancer cases and 33.93% of cancer-related deaths nationwide. Early detection, diagnosis, and treatment of these cancers have proven to be effective strategies for cancer prevention and control, serving as key measures to reduce mortality rates and improve survival outcomes.

Gastrointestinal tumors are also highly prevalent in our province. According to the 2022 Shandong Provincial Tumor Registry Annual Report, approximately 27,000 new cases of upper gastrointestinal cancers (including esophageal and gastric cancers) and colorectal cancer were recorded in registered areas, representing 24.71% of all malignant tumor cases. Deaths from these cancers reached about 16,300, accounting for 24.11% of all cancer-related deaths.

In recent years, with support from national public health funding, the Shandong Cancer Center has organized screening programs across the province, completing over 600,000 screenings for upper gastrointestinal and colorectal cancers. These efforts have detected more than 13,000 cases of precancerous or early-stage lesions, with a positive detection rate of 2.23%. Among these, 10,500 cases were diagnosed at an early stage, achieving an early diagnosis rate exceeding 80%, demonstrating significant societal benefits. Regions such as Feicheng, Linqu, and Dongping have established early diagnosis and treatment centers for upper gastrointestinal cancers, enabling comprehensive full-cycle management from screening to treatment and follow-up. This progress lays a crucial foundation for large-scale, long-term cohort studies.

This research is based on the ongoing Shandong Gastrointestinal Cancer Screening Cohort and will collect plasma samples from 4,000 individuals undergoing simultaneous screening for esophageal, gastric, and colorectal cancers. The study will utilize an independently developed multi-cancer early detection (MCED) liquid biopsy technology for performance validation.

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.