Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
450 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-10-11
Study Completion Date
2025-06-01
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.
Therefore, 450 patients at least 18 years of age with hepatobiliary tumors were included in this study.
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Detailed Description
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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
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
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
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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hepatobiliary tumor patients
benign or malignant hepatobiliary tumors patients
Gene expression analysis
Intervention Type
OTHER
Gene expression analysis
Genomic analysis
Intervention Type
OTHER
Genomic analysis
Protein expression analysis
Intervention Type
OTHER
Protein expression analysis
Proteomic profiling
Intervention Type
OTHER
Proteomic profiling
Polymerase chain reaction
Intervention Type
OTHER
Polymerase chain reaction
Mass spectrometry
Intervention Type
OTHER
Mass spectrometry
Immunohistochemistry
Intervention Type
OTHER
Immunohistochemistry
Metabolomics profiling
Intervention Type
OTHER
Metabolomics profiling
Methylation and epigenetic analysis
Intervention Type
OTHER
Methylation and epigenetic analysis
Liquid biopsy analysis
Intervention Type
OTHER
Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis
Laboratory biomarker analysis
Intervention Type
OTHER
Laboratory biomarker analysis (such as AFP, CA19-9, CEA)
Benign Hepatobiliary Disease
chronic hepatitis, cirrhosis, and healthy control
Gene expression analysis
Intervention Type
OTHER
Gene expression analysis
Genomic analysis
Intervention Type
OTHER
Genomic analysis
Protein expression analysis
Intervention Type
OTHER
Protein expression analysis
Proteomic profiling
Intervention Type
OTHER
Proteomic profiling
Polymerase chain reaction
Intervention Type
OTHER
Polymerase chain reaction
Mass spectrometry
Intervention Type
OTHER
Mass spectrometry
Immunohistochemistry
Intervention Type
OTHER
Immunohistochemistry
Metabolomics profiling
Intervention Type
OTHER
Metabolomics profiling
Methylation and epigenetic analysis
Intervention Type
OTHER
Methylation and epigenetic analysis
Liquid biopsy analysis
Intervention Type
OTHER
Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis
Laboratory biomarker analysis
Intervention Type
OTHER
Laboratory biomarker analysis (such as AFP, CA19-9, CEA)
Interventions
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Gene expression analysis
Gene expression analysis
Intervention Type
OTHER
Genomic analysis
Genomic analysis
Intervention Type
OTHER
Protein expression analysis
Protein expression analysis
Intervention Type
OTHER
Proteomic profiling
Proteomic profiling
Intervention Type
OTHER
Polymerase chain reaction
Polymerase chain reaction
Intervention Type
OTHER
Mass spectrometry
Mass spectrometry
Intervention Type
OTHER
Immunohistochemistry
Immunohistochemistry
Intervention Type
OTHER
Metabolomics profiling
Metabolomics profiling
Intervention Type
OTHER
Methylation and epigenetic analysis
Methylation and epigenetic analysis
Intervention Type
OTHER
Liquid biopsy analysis
Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis
Intervention Type
OTHER
Laboratory biomarker analysis
Laboratory biomarker analysis (such as AFP, CA19-9, CEA)
Intervention Type
OTHER
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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OrigiMed
INDUSTRY
Sponsor Role
collaborator
GeneCast Biotechnology Co., Ltd.
INDUSTRY
Sponsor Role
collaborator
YuceBio Technology Co., Ltd.
UNKNOWN
Sponsor Role
collaborator
Geneplus-Beijing Co. Ltd.
INDUSTRY
Sponsor Role
collaborator
Peking Union Medical College Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Haitao Zhao, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.
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BACKGROUND
Cancer Genome Atlas Research Network. Electronic address: [email protected]; Cancer Genome Atlas Research Network. Comprehensive and Integrative Genomic Characterization of Hepatocellular Carcinoma. Cell. 2017 Jun 15;169(7):1327-1341.e23. doi: 10.1016/j.cell.2017.05.046.
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BACKGROUND
Jiang Y, Sun A, Zhao Y, Ying W, Sun H, Yang X, Xing B, Sun W, Ren L, Hu B, Li C, Zhang L, Qin G, Zhang M, Chen N, Zhang M, Huang Y, Zhou J, Zhao Y, Liu M, Zhu X, Qiu Y, Sun Y, Huang C, Yan M, Wang M, Liu W, Tian F, Xu H, Zhou J, Wu Z, Shi T, Zhu W, Qin J, Xie L, Fan J, Qian X, He F; Chinese Human Proteome Project (CNHPP) Consortium. Proteomics identifies new therapeutic targets of early-stage hepatocellular carcinoma. Nature. 2019 Mar;567(7747):257-261. doi: 10.1038/s41586-019-0987-8. Epub 2019 Feb 27.
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BACKGROUND
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BACKGROUND
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Toyoda H, Kumada T, Tada T, Niinomi T, Ito T, Kaneoka Y, Maeda A. Prognostic significance of a combination of pre- and post-treatment tumor markers for hepatocellular carcinoma curatively treated with hepatectomy. J Hepatol. 2012 Dec;57(6):1251-7. doi: 10.1016/j.jhep.2012.07.018. Epub 2012 Jul 20.
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Wang Y, Li J, Xia Y, Gong R, Wang K, Yan Z, Wan X, Liu G, Wu D, Shi L, Lau W, Wu M, Shen F. Prognostic nomogram for intrahepatic cholangiocarcinoma after partial hepatectomy. J Clin Oncol. 2013 Mar 20;31(9):1188-95. doi: 10.1200/JCO.2012.41.5984. Epub 2013 Jan 28.
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Other Identifiers
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JS-2296
Identifier Type: -
Identifier Source: org_study_id
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