Early screening for esophageal, stomach, and colorectal cancers

Liquid Biopsy for Early Screening Cohort Study of Multiple Gastrointestinal Tumors

This project will collect blood plasma from adults 40–75 who are having gastrointestinal cancer screening to test a multi-cancer early detection blood test for esophageal, gastric, and colorectal cancers.

Quick facts

• Study type: Observational
• Enrollment: 4000 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Shandong Cancer Hospital and Institute (other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07106424 on ClinicalTrials.gov

What this trial studies

This observational project uses the Shandong Province Tumor Screening and Early Diagnosis & Treatment Platform and the ongoing Shandong Gastrointestinal Cancer Screening Cohort to collect samples. Researchers will collect 4,000 plasma samples from adults aged 40–75 undergoing simultaneous endoscopic and colorectal screening, with linkage to clinical and pathology results. Nanjing Shihe Medical Laboratory's multi-cancer early detection blood test will be applied to the samples to compare test findings with screening and diagnostic outcomes. The aim is to see if the blood test can identify esophageal, gastric, and colorectal cancers at earlier stages than symptom-driven detection.

Who should consider this trial

Good fit: Ideal candidates are adults 40–75 years old without a prior cancer diagnosis who are participating in local simultaneous esophageal, gastric, and colorectal cancer screening and who can safely undergo endoscopy.

Not a fit: People outside the 40–75 age range, those with a prior cancer diagnosis, pregnant individuals, or those with severe cardiopulmonary disease, bleeding disorders, or inability to tolerate endoscopy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the blood test could detect gastrointestinal cancers earlier, enabling earlier treatment, fewer advanced cases, and reduced mortality.

How similar studies have performed: Similar blood-based multi-cancer early detection tests (for example cfDNA methylation assays) have shown promising early detection results in other cohorts, but population-level effectiveness for gastrointestinal cancers remains under study.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Jinming Yu

Conditions: Early Detection of Cancer