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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991947
• Other study ID #: IRB-2023-427
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Zhejiang Cancer Hospital
• Contact: Xiangdong Cheng, Professor
• Phone: +86-13968032995
• Email: chengxd[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Healthy
• Stomach Neoplasms

Intervention

Other:
• No intervention
No intervention measures are needed.

Locations

Country	Name	City	State
China	Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in ctDNA gene and tumor-specific proteins expression	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.	First day in hospital