Benign Hepatobiliary Disease, Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer, Healthy, no Evidence of Disease, Hepatocellular Carcinoma, Liver Cancer, Precancerous Condition
Conditions
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
Interventions
OTHERGene expression analysis
Gene expression analysis
OTHERGenomic analysis
Genomic analysis
OTHERProtein expression analysis
Protein expression analysis
OTHERProteomic profiling
Proteomic profiling
OTHERPolymerase chain reaction
Polymerase chain reaction
OTHERMass spectrometry
Mass spectrometry
OTHERImmunohistochemistry
Immunohistochemistry
OTHERMetabolomics profiling
Metabolomics profiling
OTHERMethylation and epigenetic analysis
Methylation and epigenetic analysis
Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis
OTHERLaboratory biomarker analysis
Laboratory biomarker analysis (such as AFP, CA19-9, CEA)
Sponsors
OrigiMed
GeneCast Biotechnology Co., Ltd.
YuceBio Technology Co., Ltd.
Geneplus-Beijing Co. Ltd.
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
China
Contacts
Primary ContactXiaoBo Yang, MD
Backup ContactHaitao Zhao, MD
Outcome results
None listed