Early screening for gastric cancer using blood samples
Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer
This study is testing whether blood samples can help detect gastric cancer earlier by looking for specific changes in DNA and proteins in both cancer patients and healthy people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05991947 on ClinicalTrials.gov |
What this trial studies
This project collects peripheral blood samples from newly diagnosed gastric cancer patients and healthy individuals to analyze differences in ctDNA mutations, fragmentomics, and protein biomarkers. Techniques such as cfDNA sequencing and proteomics will be employed to establish a comprehensive diagnostic model for gastric cancer. The study aims to validate the diagnostic value of this model in terms of sensitivity, specificity, and accuracy. A total of 700 gastric cancer patients and 700 healthy individuals will participate across multiple hospitals in China.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-100 with pathologically confirmed Stage I-III gastric cancer who have not received any prior anti-tumor treatment.
Not a fit: Patients with other hereditary diseases, severe inflammatory reactions, or those who have undergone recent organ transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate and early diagnostic method for gastric cancer.
How similar studies have performed: Other studies utilizing similar diagnostic approaches have shown promise, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Xiangdong Cheng, Professor
- Email: chengxd@zjcc.org.cn
- Phone: +86-13968032995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.