Detecting liver cancer early using blood protein analysis
Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood: a Prospective Study
This study is testing if analyzing blood proteins can help doctors find liver cancer earlier in people who have it, have benign lesions, or are healthy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | immunotherapy, methotrexate, cyclophosphamide |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06544083 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish an early diagnosis model for hepatocellular carcinoma by analyzing blood protein profiles from patients with liver cancer, benign lesions, and healthy individuals. Blood samples will be collected and compared to identify biomarkers that can accurately diagnose liver cancer at an early stage. The study is divided into two phases: model establishment, where samples are collected from various subjects, and model validation, which involves a single-blind analysis of the collected data across multiple centers. The goal is to enhance early detection methods for liver cancer, potentially improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 who have recently been diagnosed or suspected of having liver cancer.
Not a fit: Patients who have undergone anti-tumor therapies or are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and earlier diagnosis of liver cancer, allowing for timely treatment.
How similar studies have performed: Other studies utilizing blood protein biomarkers for cancer detection have shown promise, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntarily sign informed consent. 2. Male or female, age equal to or greater than 18 years and less than 75 years. 3. Patients with liver cancer who have been diagnosed or suspected for the first time within 42 days prior to blood collection 4. The subject has not undergone any local or systemic anti-tumor therapy before blood collection, including (but not limited to) tumor surgical treatment for any purpose, local or systemic chemoradiotherapy, targeted therapy (including anti-angiogenic drugs), immunotherapy, cancer vaccine and hormone therapy, etc. 5. Patients with histologically or cytological, radiographically confirmed hepatocellular carcinoma. Exclusion Criteria: 1. Female subjects who are pregnant or breastfeeding. 2. Previous organ transplantation or non-autologous bone marrow or stem cell transplantation. 3. Received drugs with anti-tumor effects for other diseases within 30 days before blood collection, such as drugs used for the treatment of immunorheumatic diseases such as methotrexate, cyclophosphamide, thiazoprine, chlorambucil, etc., drugs for the treatment of breast diseases, such as tamoxifen, etc. 4. History of previous malignant tumors. 5. Having other malignant tumors or multiple primary tumors at the same time.
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Weilin Wang — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
- Study coordinator: Weilin Wang
- Email: wam@zju.edu.cn
- Phone: 13606642087
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.