Early Screening Cohort Study of Multiple Gastrointestinal Tumors

NCT07106424 | Recruiting DMC

• 1 other identifier: DECIPHER-GASTRO
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Early Detection of Cancer

Outcome Measures

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.

  2024.7-2027.7

Study Arms (1)

gastrointestinal tumor screening

They will undergo cancer screening based on liquid biopsy as well as routine gastrointestinal endoscopy screening simultaneously.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals undergoing screening for esophageal cancer, gastric cancer, and colorectal cancer within the Shandong Province gastrointestinal screening cohort aged 40-74 years.

You may qualify if:

• gastrointestinal cancer screening population
• age 40-75
• no prior history of tumors

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

plasma

Central Study Contacts

Jinming Yu

CONTACT

0531-67626929; sdzlllh803@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician of the Chinese Academy of Engineering, President of Shandong Cancer Hospital

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 10, 2028
• Study Completion (Estimated): September 10, 2030
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

CN (1)