Hepatobiliary Tumors Tissue Samples Acquisition

NCT04445532 | Unknown

• 1 other identifier: JS-2296
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Cholangiocarcinoma; Gallbladder Cancer; Biliary Tract Cancer; Liver Cancer; Precancerous Condition; Benign Hepatobiliary Disease; Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• Collected samples

  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 Outcomes (4)

• Biomarkers of resectable disease-free recurrence (DFS) and overall survival (OS)

  through study completion, an average of 5 years

• Biomarkers of evolution of tumors and discover specific diagnostic markers for hepatobiliary tumors

  through study completion, an average of 5 years

• Biomarkers of the efficacy of target and immunotherapy for advanced hepatobiliary tumors

  through study completion, an average of 5 years

• Multi-omics analysis to further type and find therapeutic targets

  through study completion, an average of 5 years

Study Arms (2)

hepatobiliary tumor patients

benign or malignant hepatobiliary tumors patients

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

Benign Hepatobiliary Disease

chronic hepatitis, cirrhosis, and healthy control

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

Interventions

Gene expression analysis OTHER

Gene expression analysis

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Genomic analysis OTHER

Genomic analysis

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Protein expression analysis OTHER

Protein expression analysis

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Proteomic profiling OTHER

Proteomic profiling

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Polymerase chain reaction OTHER

Polymerase chain reaction

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Mass spectrometry OTHER

Mass spectrometry

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Immunohistochemistry OTHER

Immunohistochemistry

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Metabolomics profiling OTHER

Metabolomics profiling

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Methylation and epigenetic analysis OTHER

Methylation and epigenetic analysis

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Liquid biopsy analysis OTHER

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

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Laboratory biomarker analysis OTHER

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

Benign Hepatobiliary Disease; hepatobiliary tumor patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatobiliary cancer, benign hepatobiliary disease, and healthy Subjects will be recruited at Peking Union Medical College Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• OrigiMed: collaborator
• GeneCast Biotechnology Co., Ltd.: collaborator
• YuceBio Technology Co., Ltd.: collaborator
• Geneplus-Beijing Co. Ltd.: collaborator

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood, urine, feces, ascites, bile samples

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma; Gallbladder Neoplasms; Biliary Tract Neoplasms; Liver Neoplasms; Precancerous Conditions

Interventions

Gene Expression Profiling; Polymerase Chain Reaction; Mass Spectrometry; Immunohistochemistry; Methylation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Nucleic Acid Amplification Techniques; Chemistry Techniques, Analytical; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Alkylation; Biochemical Phenomena; Chemical Phenomena; Organic Chemistry Phenomena; Metabolism

Study Officials

• Haitao Zhao, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XiaoBo Yang, MD

CONTACT

+86-138-1167-5126; yangxiaobo67@pumch.cn

Haitao Zhao, MD

CONTACT

zhaoht@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 24, 2020
• Study Start: October 11, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 7, 2023

Record last verified: 2023-03

Locations

CN (1)