Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer
NCT ID: NCT05991947
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1100 participants
OBSERVATIONAL
2021-03-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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gastric cancer patients
No intervention
No intervention measures are needed.
healthy individuals
No intervention
No intervention measures are needed.
Interventions
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No intervention
No intervention measures are needed.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
Yes
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Xiangdong Cheng
Secretary of the party committee
Locations
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Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-2023-427
Identifier Type: -
Identifier Source: org_study_id
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