Hepatobiliary Tumors Tissue Samples Acquisition

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    450
  • sponsor
    Peking Union Medical College Hospital
Updated on 1 July 2022
cancer
PCR test
immunohistochemistry
primary cancer
targeted therapy
gene expression
Accepts healthy volunteers

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.

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

Details
Condition Hepatocellular Carcinoma, Cholangiocarcinoma, Gallbladder Cancer, Biliary Tract Cancer, Liver Cancer, Precancerous Condition, Benign Hepatobiliary Disease, Healthy, no Evidence of Disease
Treatment laboratory biomarker analysis, polymerase chain reaction, Gene Expression Analysis, proteomic profiling, mass spectrometry, protein expression analysis, Immunohistochemistry, Genomic analysis, Metabolomics profiling, Methylation and epigenetic analysis, Liquid biopsy analysis
Clinical Study IdentifierNCT04445532
SponsorPeking Union Medical College Hospital
Last Modified on1 July 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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