Monitoring liver cancer recurrence using blood tests after treatment
Clinical Research on Dynamic Monitoring MRD Via Plasma ctDNA Predicting Postoperative Recurrence and Progression After Systemic Therapy of Hepatocellular Carcinoma
This study is testing if blood tests that check for tumor DNA can help people who have had liver cancer surgery or treatment find out if their cancer might come back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 475 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Singlera Genomics Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06178809 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with hepatocellular carcinoma (HCC) who have undergone surgery or systemic therapy. It aims to establish a precise method for detecting minimal residual disease (MRD) through the analysis of circulating tumor DNA (ctDNA) in plasma. Patients will have their blood collected at multiple follow-up visits, and genomic characteristics will be correlated with recurrence or progression of the disease. The study will evaluate the sensitivity and specificity of the ctDNA detection method to predict relapse risk.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 diagnosed with primary hepatocellular carcinoma who have not received any prior treatment for liver cancer.
Not a fit: Patients with other malignancies or those who have undergone significant surgical treatments recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for early detection of liver cancer recurrence, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring cancer recurrence, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-80 years old (including 80 years old), gender is not limited; 2. Patients diagnosed with primary HCC; 3. ECOG score ≤1; 4. no previous malignant tumors, including liver cancer; 5. Before blood collection, the patient had not received any treatment related to liver cancer, including surgery, transplantation, radiotherapy, chemotherapy, etc.; 6. Survival period of ≥3 years as initially assessed by researchers; 7. Those who are fully aware of this study and voluntarily sign the informed consent. Exclusion Criteria: 1. Patients diagnosed with esophageal cancer, gastric cancer, colorectal cancer, lung cancer, pancreatic cancer, breast cancer and other malignant tumors; 2. Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months; 3. Participate in other interventional clinical investigators within 3 months; 4. Pregnant or lactating women; 5. Patients with autoimmune diseases, genetic diseases, mental disorders/disabilities, substance abuse and other diseases deemed unsuitable for participation in the study by the researchers; 6. Poor compliance, according to the judgment of the researcher can not complete the study.
Where this trial is running
Shanghai, Shanghai
- Fudan university Zhongshan Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jian Zhou, MD — Shanghai Zhongshan Hospital
- Study coordinator: Jian Zhou, MD
- Email: zhou.jian@zs-hospital.sh.cn
- Phone: +86 13801914007
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.