Hepatobiliary Tumors Tissue Samples Acquisition

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04445532
• Other study ID #: JS-2296
• Status: Recruiting
• Start date: October 11, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: XiaoBo Yang, MD
• Phone: +86-138-1167-5126
• Email: yangxiaobo67[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Hepatobiliary Disease
• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Cholangiocarcinoma
• Digestive System Diseases
• Gallbladder Cancer
• Gallbladder Neoplasms
• Healthy, no Evidence of Disease
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Diseases
• Precancerous Condition
• Precancerous Conditions

Intervention

Other:
• Gene expression analysis
Gene expression analysis
• Genomic analysis
Genomic analysis
• Protein expression analysis
Protein expression analysis
• Proteomic profiling
Proteomic profiling
• Polymerase chain reaction
Polymerase chain reaction
• Mass spectrometry
Mass spectrometry
• Immunohistochemistry
Immunohistochemistry
• Metabolomics profiling
Metabolomics profiling
• Methylation and epigenetic analysis
Methylation and epigenetic analysis
• Liquid biopsy analysis
Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis
• Laboratory biomarker analysis
Laboratory biomarker analysis (such as AFP, CA19-9, CEA)

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences & Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	GeneCast Biotechnology Co., Ltd., Geneplus-Beijing Co. Ltd., OrigiMed, YuceBio Technology Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

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