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Hepatobiliary Tumors Tissue Samples Acquisition

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04445532
Collaborator
OrigiMed (Industry), GeneCast Biotechnology Co., Ltd. (Industry), YuceBio Technology Co., Ltd. (Other)
450
Enrollment
1
Location
55.7
Anticipated Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

Study Design

Study Type:
Observational
Anticipated Enrollment :
450 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors
Actual Study Start Date :
Oct 11, 2020
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Biomarkers of resectable disease-free recurrence (DFS) and overall survival (OS) [through study completion, an average of 5 years]

  2. Biomarkers of evolution of tumors and discover specific diagnostic markers for hepatobiliary tumors [through study completion, an average of 5 years]

  3. Biomarkers of the efficacy of target and immunotherapy for advanced hepatobiliary tumors [through study completion, an average of 5 years]

  4. Multi-omics analysis to further type and find therapeutic targets [through study completion, an average of 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese Academy of Medical Sciences & Peking Union Medical College Hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital
  • OrigiMed
  • GeneCast Biotechnology Co., Ltd.
  • YuceBio Technology Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT04445532
Other Study ID Numbers:
  • JS-2296
First Posted:
Jun 24, 2020
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cholangiocarcinoma
Biliary Tract Neoplasms
Gallbladder Neoplasms
Precancerous Conditions
Digestive System Diseases
Liver Diseases

Study Results

No Results Posted as of Jun 10, 2022