Actively Recruiting
Liquid Biopsy for Early Screening Cohort Study of Multiple Gastrointestinal Tumors
Led by Shandong Cancer Hospital and Institute · Updated on 2025-08-06
4000
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastrointestinal tumors such as esophageal, gastric, and colorectal cancers are common and serious in Shandong Province, China. These cancers often go undetected until they reach an advanced stage, leading to higher treatment costs and worse outcomes. Early detection through screening is important to improve cure rates and reduce deaths. This research builds on an ongoing screening program and aims to study the use of a new liquid biopsy test for early detection of multiple gastrointestinal cancers. The study will enroll 4,000 individuals aged 40 to 75 undergoing screening for the three types of gastrointestinal cancers. Participants will have simultaneous cancer screening using both the liquid biopsy test and routine endoscopic methods like gastroscopy and colonoscopy. The liquid biopsy product was developed by Nanjing Shihe Medical Laboratory and is designed to detect multiple cancers early through a blood sample. During the study, participants will provide plasma samples and undergo standard endoscopic screenings. Researchers will compare the liquid biopsy results with endoscopy findings to assess how well the blood test detects high-grade or more advanced cancers. The main outcome measured is the sensitivity of the liquid biopsy for detecting these cancers. The study runs from 2024 to 2027, with ongoing monitoring and follow-up to evaluate screening performance and safety.
CONDITIONS
Brief Title
Early Screening Cohort Study of Multiple Gastrointestinal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals undergoing gastrointestinal cancer screening
- Aged between 40 and 75 years
- No prior history of tumors
You will not qualify if you...
- Severe heart disease or heart failure
- Severe respiratory disease, ongoing asthma, or serious brain diseases
- Severe spinal deformity or aneurysms
- Physically unable to tolerate endoscopy or difficulty remaining calm during procedure
- Acute corrosive inflammation or suspected gastrointestinal perforation
- Large ascites, severe abdominal swelling, or severe esophageal varices
- Bleeding tendencies or taking anticoagulant medications without proper discontinuation and normal coagulation
- Pregnant women
- History of iodine allergy
- Prior diagnosis or history of tumors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants undergo cancer screening using a multi-cancer early detection liquid biopsy and routine gastrointestinal endoscopy.
1 to 2 visits depending on screening schedule
Duration - Up to 6 years
Participants are followed over time to monitor for detection of high-grade gastrointestinal cancers and related outcomes.
Trial Site Locations
Total: 1 location
1
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
J
Jinming Yu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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