Hepatobiliary Tumors Tissue Samples Acquisition

Study Overview
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Brief Summary
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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
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OBJECTIVES: Observe the biomarkers of resectable hepatobiliary tumor recurrence (DFS) and survival (OS); Observe the evolution of tumors and discover specific diagnostic markers as a control group. Observe the response (ORR), progression (PFS) and survival (OS) biomarkers of targeted immunotherapy for advanced hepatobiliary tumors; To elaborate on the multi-omics study of hepatobiliary tumors, to further subtype and find therapeutic targets

Official Title
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Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors

Conditions
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Hepatocellular Carcinoma, Cholangiocarcinoma, Gallbladder Cancer, Biliary Tract Cancer, Liver Cancer, Precancerous Condition, Benign Hepatobiliary Disease, Healthy, no Evidence of Disease

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be older than 18 years old; ECOG 0-2 points; May have received treatment; Clinical consideration or diagnosis of benign and malignant hepatobiliary tumors; or chronic hepatitis, cirrhosis, or healthy control participants; Patients may have received or are about to undergo surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy, etc.; Patients understand and are willing to sign written informed consent documents. Exclusion Criteria: The doctor thinks it is not suitable to enter the group (mental disorder or poor compliance, etc.) Pregnant women; Active or uncontrollable infections (fungi, bacteria, etc.); Estimated survival time <12 weeks; If the patient is receiving chronic anticoagulant therapy, the anticoagulant withdrawal should not be shorter than 3 days; In the evaluation of the doctor, there is a risk of uncontrolled complications in the biopsy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hepatobiliary tumor patients<br>benign or malignant hepatobiliary tumors patients | Other: Gene expression analysis<br>* Gene expression analysis<br>Other: Genomic analysis<br>* Genomic analysis<br>Other: Protein expression analysis<br>* Protein expression analysis<br>Other: Proteomic profiling<br>* Proteomic profiling<br>Other: Polymerase chain reaction<br>* Polymerase chain reaction<br>Other: Mass spectrometry<br>* Mass spectrometry<br>Other: Immunohistochemistry<br>* Immunohistochemistry<br>Other: Metabolomics profiling<br>* Metabolomics profiling<br>Other: Methylation and epigenetic analysis<br>* Methylation and epigenetic analysis<br>Other: Liquid biopsy analysis<br>* Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis<br>Other: Laboratory biomarker analysis<br>* Laboratory biomarker analysis (such as AFP, CA19-9, CEA)<br>|
| Benign Hepatobiliary Disease<br>chronic hepatitis, cirrhosis, and healthy control | Other: Gene expression analysis<br>* Gene expression analysis<br>Other: Genomic analysis<br>* Genomic analysis<br>Other: Protein expression analysis<br>* Protein expression analysis<br>Other: Proteomic profiling<br>* Proteomic profiling<br>Other: Polymerase chain reaction<br>* Polymerase chain reaction<br>Other: Mass spectrometry<br>* Mass spectrometry<br>Other: Immunohistochemistry<br>* Immunohistochemistry<br>Other: Metabolomics profiling<br>* Metabolomics profiling<br>Other: Methylation and epigenetic analysis<br>* Methylation and epigenetic analysis<br>Other: Liquid biopsy analysis<br>* Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis<br>Other: Laboratory biomarker analysis<br>* Laboratory biomarker analysis (such as AFP, CA19-9, CEA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collected samples | Collected normal tissue, tumor samples, blood, urine, feces, ascites, bile samples from patients with hepatobiliary cancers | through study completion, an average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Biomarkers of the efficacy of target and immunotherapy for advanced 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 |