AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies

Hepatobiliary Malignancies Clinical Trial

— ASCEND-Hep  

Official title:

Development and Validation of the Performance of a cfDNA Methylation-based Model Combined With Serum Tumor Markers for Early Hepatobiliary Malignancies Detection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04835675
• Other study ID #: ZJYY-2020006
• Status: Completed
• Start date: March 12, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2021
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria for All the Participants:

• 40-75 years old

• Ability to comply with study procedures

• Ability to provide a written informed consent

Exclusion Criteria for All the Participants:

• Pregnancy or lactating women

• Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant

• Recipients of blood transfusion within 7 days prior to study blood draw

• Recipients of anti-microbial therapy within 14 days prior to study blood draw

• Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer

Inclusion Criteria for Cancer Arm Participants:

• Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies

• No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

• Current diagnosis of other malignancies or multiple primary tumors

• Diagnosis of benign diseases by histopathological assessments

• Inability to characterize whether the lesion is malignant or benign

• Prior or ongoing treatment of cancer

Inclusion Criteria for Benign Diseases Arm Participants:

• Confirmed diagnosis of benign diseases of the hepatobiliary system

• No prior radical treatment of the benign diseases prior to study blood draw

Exclusion Criteria for Benign Diseases Arm Participants:

• Current or history of malignancies or precancerous lesions

• No confirmed diagnosis or inability to characterize a benign disease

Related Conditions & MeSH terms

• Hepatobiliary Malignancies
• Neoplasms

Intervention

Device:
• Multi-cancer early detection test
Blood collection and multi-cancer early detection testing

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhujiang Hospital	Guangzhou BR

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98%		16 months
Primary	Sensitivity and specificity of early hepatobiliary malignancies detection and TOO accuracy of a cfDNA methylation-based model combined with serum tumor markers		16 months
Secondary	Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in early detection of hepatobiliary malignancies in different stages		16 months
Secondary	Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers, clinical characteristics and other biomarkers		16 months
Secondary	Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with malignant or benign diseases of the hepatobiliary system		16 months
Secondary	Sensitivity and specificity of a cfDNA methylation-based model or serum tumor markers in participants with hepatobiliary malignancies		16 months