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

University of Chinese Academy Sciences

Status

Enrolling

Conditions

Healthy

Gastric Cancer

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT05991947

IRB-2023-427

Details and patient eligibility

About

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.

Enrollment

1,100 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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.