AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies (ASCEND-Hep)

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatobiliary Malignancies
• Intervention / Treatment: Device: Multi-cancer early detection test

• Study Type: Observational
• Enrollment (Actual): 496

Contacts and Locations

• Study Contact: Name: Mingxin Pan, M.D.; Phone Number: +86-020-62782562; Email: pmxwxy@sohu.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of hepatobiliary malignancies and benign diseases of the hepatobiliary system.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer Arm; Participants with new diagnosis of hepatobiliary malignancies, from whom blood samples will be collected	Device: Multi-cancer early detection test; Blood collection and multi-cancer early detection testing
Benign Diseases Arm; Participants with benign diseases of the hepatobiliary system, from whom blood samples will be collected	Device: Multi-cancer early detection test; Blood collection and multi-cancer early detection testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
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
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers, clinical characteristics and other biomarkers	16 months
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
Sensitivity and specificity of a cfDNA methylation-based model or serum tumor markers in participants with hepatobiliary malignancies	16 months

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: Guangzhou BR
• Investigators: Principal Investigator: Mingxin Pan, Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Liquid biopsy; Cell-free DNA; Early detection; Hepatobiliary malignancies
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ZJYY-2020006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No