Early screening for esophageal, stomach, and colorectal cancers
Official title: Liquid Biopsy for Early Screening Cohort Study of Multiple Gastrointestinal Tumors
Run by Shandong Cancer Hospital and Institute · NCT07106424 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 40 Years to 75 Years |
| Sex | All |
| Enrollment | 4000 (estimated) |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | September 10, 2024 |
| Main results expected | September 10, 2028 |
| Study ends | September 10, 2030 |
| Registry record updated | August 6, 2025 |
| Trial ID | NCT07106424 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: Jinming Yu
- Email: sdzlllh803@126.com
- Phone: 0531-67626929
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.