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Hepatobiliary Tumors Tissue Samples Acquisition

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ClinicalTrials.gov Identifier: NCT04445532
Recruitment Status : Not yet recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Collaborators:
OrigiMed., Inc.
GeneCast Biotechnology Co., Ltd.
YuceBio Technology Co., Ltd.
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Hepatocellular Carcinoma Cholangiocarcinoma Gallbladder Cancer Biliary Tract Cancer Liver Cancer Precancerous Condition Benign Hepatobiliary Disease Healthy, no Evidence of Disease 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

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

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025


Group/Cohort Intervention/treatment
hepatobiliary tumor patients
benign or malignant hepatobiliary tumors patients
Other: Gene expression analysis
Gene expression analysis

Other: Genomic analysis
Genomic analysis

Other: Protein expression analysis
Protein expression analysis

Other: Proteomic profiling
Proteomic profiling

Other: Polymerase chain reaction
Polymerase chain reaction

Other: Mass spectrometry
Mass spectrometry

Other: Immunohistochemistry
Immunohistochemistry

Other: Metabolomics profiling
Metabolomics profiling

Other: Methylation and epigenetic analysis
Methylation and epigenetic analysis

Other: Liquid biopsy analysis
Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis

Other: Laboratory biomarker analysis
Laboratory biomarker analysis (such as AFP, CA19-9, CEA)

Benign Hepatobiliary Disease
chronic hepatitis, cirrhosis, and healthy control
Other: Gene expression analysis
Gene expression analysis

Other: Genomic analysis
Genomic analysis

Other: Protein expression analysis
Protein expression analysis

Other: Proteomic profiling
Proteomic profiling

Other: Polymerase chain reaction
Polymerase chain reaction

Other: Mass spectrometry
Mass spectrometry

Other: Immunohistochemistry
Immunohistochemistry

Other: Metabolomics profiling
Metabolomics profiling

Other: Methylation and epigenetic analysis
Methylation and epigenetic analysis

Other: Liquid biopsy analysis
Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis

Other: Laboratory biomarker analysis
Laboratory biomarker analysis (such as AFP, CA19-9, CEA)




Primary Outcome Measures :
  1. Collected samples [ Time Frame: 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 :
  1. Biomarkers of resectable disease-free recurrence (DFS) and overall survival (OS) [ Time Frame: through study completion, an average of 5 years ]
  2. Biomarkers of evolution of tumors and discover specific diagnostic markers for hepatobiliary tumors [ Time Frame: through study completion, an average of 5 years ]
  3. Biomarkers of the efficacy of target and immunotherapy for advanced hepatobiliary tumors [ Time Frame: through study completion, an average of 5 years ]
  4. Multi-omics analysis to further type and find therapeutic targets [ Time Frame: through study completion, an average of 5 years ]

Biospecimen Retention:   Samples With DNA
Tissue, blood, urine, feces, ascites, bile samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hepatobiliary cancer, benign hepatobiliary disease, and healthy Subjects will be recruited at Peking Union Medical College Hospital.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445532


Contacts
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Contact: XiaoBo Yang, MD +86-138-1167-5126 yangxiaobo67@pumch.cn
Contact: Haitao Zhao, MD zhaoht@pumch.cn

Locations
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China, Beijing
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Contact: Xu Yang, MD    +86 158-1066-7683 ext 010-69156043    yangxulcyx@163.com   
Contact: Haitao Zhao, MD       zhaoht@pumch.cn   
Sub-Investigator: Xiaobo Yang, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
OrigiMed., Inc.
GeneCast Biotechnology Co., Ltd.
YuceBio Technology Co., Ltd.
Investigators
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Principal Investigator: Haitao Zhao, MD Peking Union Medical College Hospital
Publications:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04445532    
Other Study ID Numbers: JS-2296
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Biliary Tract Neoplasms
Gallbladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Carcinoma, Hepatocellular
Precancerous Conditions
Liver Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Biliary Tract Diseases
Gallbladder Diseases