Hepatobiliary Tumors Tissue Samples Acquisition

Recruiting

• Conditions: Hepatocellular Carcinoma; Cholangiocarcinoma; Precancerous Condition; Benign Hepatobiliary Disease; Healthy, no Evidence of Disease; Biliary Tract Cancer; Liver Cancer; Gallbladder Cancer
• Interventions: Other: Gene expression analysis; Other: Genomic analysis; Other: Protein expression analysis; Other: Proteomic profiling; Other: Polymerase chain reaction; Other: Mass spectrometry; Other: Immunohistochemistry; Other: Metabolomics profiling; Other: Methylation and epigenetic analysis; Other: Liquid biopsy analysis; Other: Laboratory biomarker analysis

• Registration Number: NCT04445532
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Hepatobiliary tumors have a poor prognosis and high individual heterogeneity, so it is of great significance to find important prognostic markers and then screen out specific subgroups of people; meanwhile, chronic hepatitis, cirrhosis, and healthy control participants also need to show the evolution of tumors and discover specific diagnostic markers as a control group. Moreover, targeted therapy and immunotherapy make cancer treatment enter a new field, but only part of patients achieve response rates and reach clinical benefit. However, these drugs are expensive and can cause treatment-related adverse events. Therefore, reliable biomarkers identification is needed to help predict the response to these treatment options in order to screen patients with better responsiveness and avoid wasting money. Multi-omics research can reveal the characteristics of hepatobiliary tumors more deeply and find meaningful therapeutic targets.

Therefore, 450 patients at least 18 years of age with hepatobiliary tumors were included in this study.

Detailed Description

OBJECTIVES:

1. Observe the biomarkers of resectable hepatobiliary tumor recurrence (DFS) and survival (OS);

2. Observe the evolution of tumors and discover specific diagnostic markers as a control group.

3. Observe the response (ORR), progression (PFS) and survival (OS) biomarkers of targeted immunotherapy for advanced hepatobiliary tumors;

4. To elaborate on the multi-omics study of hepatobiliary tumors, to further subtype and find therapeutic targets

Study Timeline

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2020-10-11
• Status Verified: 2023-03
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-07
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benign Hepatobiliary Disease	Protein expression analysis	chronic hepatitis, cirrhosis, and healthy control
Benign Hepatobiliary Disease	Proteomic profiling	chronic hepatitis, cirrhosis, and healthy control
Benign Hepatobiliary Disease	Polymerase chain reaction	chronic hepatitis, cirrhosis, and healthy control
Benign Hepatobiliary Disease	Immunohistochemistry	chronic hepatitis, cirrhosis, and healthy control
hepatobiliary tumor patients	Proteomic profiling	benign or malignant hepatobiliary tumors patients
hepatobiliary tumor patients	Polymerase chain reaction	benign or malignant hepatobiliary tumors patients
Benign Hepatobiliary Disease	Gene expression analysis	chronic hepatitis, cirrhosis, and healthy control
hepatobiliary tumor patients	Genomic analysis	benign or malignant hepatobiliary tumors patients
hepatobiliary tumor patients	Protein expression analysis	benign or malignant hepatobiliary tumors patients
hepatobiliary tumor patients	Metabolomics profiling	benign or malignant hepatobiliary tumors patients
hepatobiliary tumor patients	Methylation and epigenetic analysis	benign or malignant hepatobiliary tumors patients
hepatobiliary tumor patients	Laboratory biomarker analysis	benign or malignant hepatobiliary tumors patients
Benign Hepatobiliary Disease	Genomic analysis	chronic hepatitis, cirrhosis, and healthy control
Benign Hepatobiliary Disease	Liquid biopsy analysis	chronic hepatitis, cirrhosis, and healthy control
hepatobiliary tumor patients	Gene expression analysis	benign or malignant hepatobiliary tumors patients
hepatobiliary tumor patients	Immunohistochemistry	benign or malignant hepatobiliary tumors patients
Benign Hepatobiliary Disease	Mass spectrometry	chronic hepatitis, cirrhosis, and healthy control
Benign Hepatobiliary Disease	Laboratory biomarker analysis	chronic hepatitis, cirrhosis, and healthy control
hepatobiliary tumor patients	Mass spectrometry	benign or malignant hepatobiliary tumors patients
hepatobiliary tumor patients	Liquid biopsy analysis	benign or malignant hepatobiliary tumors patients
Benign Hepatobiliary Disease	Metabolomics profiling	chronic hepatitis, cirrhosis, and healthy control
Benign Hepatobiliary Disease	Methylation and epigenetic analysis	chronic hepatitis, cirrhosis, and healthy control

Primary Outcome Measures

Name	Time	Method
Collected samples	through study completion, an average of 5 years	Collected normal tissue, tumor samples, blood, urine, feces, ascites, bile samples from patients with hepatobiliary cancers

Secondary Outcome Measures

Name	Time	Method
Biomarkers of resectable disease-free recurrence (DFS) and overall survival (OS)	through study completion, an average of 5 years
Biomarkers of evolution of tumors and discover specific diagnostic markers for hepatobiliary tumors	through study completion, an average of 5 years
Multi-omics analysis to further type and find therapeutic targets	through study completion, an average of 5 years
Biomarkers of the efficacy of target and immunotherapy for advanced hepatobiliary tumors	through study completion, an average of 5 years

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China