NCT05991947 Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer
| NCT ID | NCT05991947 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang Cancer Hospital |
| Condition | Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,100 participants in total. It began in 2021-03-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05991947 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05991947 currently recruiting?
Yes, NCT05991947 is actively recruiting participants. Contact the research team at chengxd@zjcc.org.cn for enrollment information.
Where is the NCT05991947 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05991947 clinical trial?
NCT05991947 is sponsored by Zhejiang Cancer Hospital. The trial plans to enroll 1,100 participants.
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