Acquisition of tissue samples from patients with hepatobiliary tumors
Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors
This study is collecting tissue samples from patients with liver and bile duct tumors to see if it can find important markers that help understand the disease and improve treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04445532 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect tissue samples from patients with hepatobiliary tumors, including hepatocellular carcinoma and cholangiocarcinoma, to identify important prognostic markers and specific subgroups. The study will also include chronic hepatitis, cirrhosis, and healthy control participants to observe tumor evolution and discover diagnostic markers. By employing multi-omics research, the study seeks to uncover the characteristics of these tumors and identify therapeutic targets, particularly in relation to the response to targeted therapies and immunotherapies. A minimum of 450 patients aged 18 and older will be enrolled to facilitate comprehensive analysis.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of benign or malignant hepatobiliary tumors, chronic hepatitis, cirrhosis, or those who are healthy controls.
Not a fit: Patients with mental disorders, poor compliance, or those who are pregnant or have active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of reliable biomarkers that predict treatment responses, ultimately improving patient outcomes and reducing unnecessary treatment costs.
How similar studies have performed: Other studies have shown success in identifying biomarkers for cancer treatment, but this multi-omics approach in hepatobiliary tumors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be older than 18 years old; 2. ECOG 0-2 points; 3. May have received treatment; 4. Clinical consideration or diagnosis of benign and malignant hepatobiliary tumors; or chronic hepatitis, cirrhosis, or healthy control participants; 5. Patients may have received or are about to undergo surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy, etc.; 6. Patients understand and are willing to sign written informed consent documents. Exclusion Criteria: 1. The doctor thinks it is not suitable to enter the group (mental disorder or poor compliance, etc.) 2. Pregnant women; 3. Active or uncontrollable infections (fungi, bacteria, etc.); 4. Estimated survival time \<12 weeks; 5. If the patient is receiving chronic anticoagulant therapy, the anticoagulant withdrawal should not be shorter than 3 days; 6. In the evaluation of the doctor, there is a risk of uncontrolled complications in the biopsy.
Where this trial is running
Beijing, Beijing
- Chinese Academy of Medical Sciences & Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Haitao Zhao, MD — Peking Union Medical College Hospital
- Study coordinator: XiaoBo Yang, MD
- Email: yangxiaobo67@pumch.cn
- Phone: +86-138-1167-5126
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.