Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer

Recruiting

• Conditions: Gastric Cancer; Healthy
• Interventions: Other: No intervention

• Registration Number: NCT05991947
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

This project aims to collect peripheral blood samples from newly diagnosed gastric cancer patients and healthy individuals. Various techniques such as cfDNA sequencing, proteomics, and fragmentomics will be employed to analyze differences in the expression of ctDNA mutations, fragmentomics, and protein biomarkers between gastric cancer patients and healthy individuals. A new comprehensive diagnostic model will be established and its diagnostic value (sensitivity, specificity, accuracy, etc.) for gastric cancer will be validated.

Specifically, the study will involve the following subjects and quantities: 700 participants from Zhejiang Cancer Hospital (350 gastric cancer patients and 350 healthy individuals), 200 participants from Sichuan Cancer Hospital (100 gastric cancer patients and 100 healthy individuals), and 200 participants from the Sixth Affiliated Hospital of Sun Yat-sen University (100 gastric cancer patients and 100 healthy individuals). Peripheral blood samples (a total of 15mL from each participant, collected in 3 tubes) will be collected from all subjects. The collected blood samples will undergo multi-omics sequencing including cfDNA methylation sequencing, proteomics, and genomics to establish a multi-omics-based early diagnostic model.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Last Update Submitted: 2023-08-07
• Study First Posted: 2023-08-15
• Last Update Posted: 2023-08-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Age between 18 and 100 years.
• ECOG performance status of 0 or 1.
• Pathologically confirmed Stage I-III gastric cancer patients.
• Patients who have not undergone any anti-tumor treatment (including chemotherapy, radiotherapy, targeted therapy, surgery, anesthesia, etc.) before blood collection.
• Subjects and their family members who can comprehend the research protocol and are willing to participate in the study, providing written informed consent.

Exclusion Criteria

• Presence of other hereditary diseases or other tumors.
• Severe inflammatory reactions caused by acute illnesses within 14 days prior to blood draw or use of steroids.
• Previous organ transplantation, stem cell transplantation, bone marrow transplantation, or blood transfusion within the last month before enrollment.
• Pregnant women.
• Participation in other clinical trials requiring medication intake within the last 60 days (including anesthesia).
• Severe cardiovascular diseases, uncontrolled infections, or other uncontrollable comorbidities.
• Subjects or family members unable to comprehend the conditions and objectives of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
gastric cancer patients	No intervention	-
healthy individuals	No intervention	-

Primary Outcome Measures

Name	Time	Method
Differences in ctDNA gene and tumor-specific proteins expression	First day in hospital	Collect 15ml of peripheral blood from subjects, extract ctDNA, and detect mutations in 18 genes (AKT1, APC, BRAF, CDKN2A, CTNNB1, EGFR, FBXW7, FGFR2, GNAS, HRAS, KRAS, NRAS, PIK3CA, PPP2R1A, PTEN, TP53, TOP2A, RNF43) and the expression levels of 9 tumor-specific proteins (CA-125, CA 19-9, CEA, HGF, IL-6, OPN, Prolactin, AFP, HE4) using the FireflyTM method based on amplicon library deep sequencing. Determine the performance indicators including sensitivity, specificity, and accuracy of the existing AccuScreen system and diagnostic model for early screening of gastric cancer. By conducting tests on 10 samples, explore the genomic fragments of gastric cancer, establish targets for ctDNA fragmentomics (fragment length, cleavage sites, end preferences, etc.), and analysis algorithms for gastric cancer fragmentomics, to further evaluate the feasibility of enhancing sensitivity and specificity for early gastric cancer screening through ctDNA fragmentomics detection.

Trial Locations

Locations (1)

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital); 🇨🇳 Hangzhou, Zhejiang, China