Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Healthy. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other No intervention
No intervention measures are needed.
Primary outcome measures
- Differences in ctDNA gene and tumor-specific proteins expression [Time frame: First day in hospital]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT05991947 · IRB-2023-427