NCT04835675

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
496

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 2, 2023

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

April 6, 2021

Last Update Submit

March 1, 2023

Conditions

Hepatobiliary Malignancies

Keywords

Hepatobiliary malignanciesLiquid biopsyCell-free DNAEarly detection

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Cancer Arm

Participants with new diagnosis of hepatobiliary malignancies, from whom blood samples will be collected

Device: Multi-cancer early detection test

Benign Diseases Arm

Participants with benign diseases of the hepatobiliary system, from whom blood samples will be collected

Device: Multi-cancer early detection test

Interventions

Multi-cancer early detection testDEVICE

Blood collection and multi-cancer early detection testing

Benign Diseases ArmCancer Arm

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • years old
  • Ability to comply with study procedures
  • Ability to provide a written informed consent

You may not qualify if:

  • 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
  • Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies
  • No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
  • 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
  • Confirmed diagnosis of benign diseases of the hepatobiliary system
  • No prior radical treatment of the benign diseases prior to study blood draw
  • Current or history of malignancies or precancerous lesions
  • No confirmed diagnosis or inability to characterize a benign disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510280, China

Location

Study Officials

  • Mingxin Pan

    Zhujiang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 8, 2021

Study Start

March 12, 2021

Primary Completion

March 31, 2022

Study Completion

June 30, 2022

Last Updated

March 2, 2023

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)