Hepatobiliary Tumors Tissue Samples Acquisition

July 5, 2023 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Xiaobo Yang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

GeneCast Biotechnology Co., Ltd.
Geneplus-Beijing Co. Ltd.
OrigiMed
YuceBio Technology Co., Ltd.

Investigators

  • Principal Investigator: Haitao Zhao, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2020

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-2296

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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