NCT05996666

Brief Summary

In the recently published multi-center, prospective, single-blind study (THUNDER study), using the methylation signal in cfDNA isolated from the peripheral blood to detect the six types of cancer, the sensitivity for liver cancer detection achieved 87.8%, with a specificity of 98.9%. In this study, a multicenter, case-control study is designed to establish an early cancer detection model based on cfDNA methylation biomarkers using qPCR to detect primary liver cancer and further validate the performance of the model.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
701

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

July 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 10, 2023

Last Update Submit

August 10, 2023

Conditions

Liver Cancer

Keywords

Early detectionLiver cancercell-free DNA (cfDNA)qPCR

Outcome Measures

Primary Outcomes (1)

  • Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR

    Sensitivity and specificity of liver cancer detection model based on selected cfDNA methylation biomarkers using qPCR in subjects with primary liver cancer or benign liver diseases, interfering cancers and healthy individuals

    2023.07.01-2023.12.30

Secondary Outcomes (4)

  • Performance of the liver cancer early detection model in detecting liver cancer at early stage

    2023.07.01-2023.12.30

  • Performance of liver cancer early detection model in detecting liver cancer at different stages and subtypes

    2023.07.01-2023.12.30

  • Performance of liver cancer early detection model to differentiate non-liver cancers

    2023.07.01-2023.12.30

  • Comparison of currently used biomarkers for liver cancer detection

    2023.07.01-2023.12.30

Study Arms (4)

Liver cancer arm

Participants with new diagnosis of liver cancer, from whom blood samples will be collected.

Device: Liver-cancer early detection test

Benign diseases arm

Participants with benign diseases of cancer, from whom blood samples will be collected.

Device: Liver-cancer early detection test

Healthy arm

Participants without known presence of malignancies or benign diseases of liver, from whom blood samples will be collected.

Device: Liver-cancer early detection test

Interfering cancer arm

Participants with new diagnosis of interfering cancer types, from whom blood samples will be collected.

Device: Liver-cancer early detection test

Interventions

Liver-cancer early detection testDEVICE

Blood collection and liver-cancer early detection test

Benign diseases armHealthy armInterfering cancer armLiver cancer arm

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants enrolled in this study included subjects with primary liver cancers, benign liver diseases, interfering cancers, and healthy individuals.

You may qualify if:

  • Individuals aged 18-74 years old
  • Individuals capable of giving signed and legally effective informed consent voluntarily
  • Individuals newly diagnosed with or suspected of having liver cancer (including hepatocellular carcinoma \[HCC\], intrahepatic cholangiocarcinoma \[ICC\], and combined hepatocellular-cholangiocarcinoma \[cHCC-CCA\]).
  • Individuals without any anti-cancer therapy prior to blood sample collection.
  • Individuals newly diagnosed as benign liver diseases before blood sample collection
  • Individuals without curative treatment for the disease before blood sample collection
  • Individuals diagnosed with or suspected of having interfering cancer
  • Individuals without any anti-cancer therapy prior to blood sample collection
  • No cancer-related or other clinical symptoms 30 days prior to blood sample collection
  • No prior history of benign liver diseases

You may not qualify if:

  • Individuals cannot provide blood samples at the study-specified blood collection sites
  • 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 blood sample collection
  • Recipients of anti-infective treatment within 14 days prior to blood sample collection
  • Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
  • Individuals with a history of malignant tumor
  • Known prior or current diagnosis of other types of malignancies or multiple primary cancers
  • No confirmed diagnosis of liver cancer after blood sample collection
  • Individuals with a confirmed diagnosis of a malignant tumor or precancerous lesion
  • Individuals who cannot be diagnosed as having benign liver diseases after blood sample collection
  • Known prior or current diagnosis of other types of malignancies or multiple primary cancers
  • No confirmed diagnosis of any type of interfering cancers after blood sample collection
  • Prior or ongoing treatment of cancers within 3 years prior to blood sample collection
  • Clinically significant or uncontrolled comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jilin university first hospital

Changchun, Jilin, China

RECRUITING

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Tian Yang

    Eastern Hepatobiliary Surgery Hospital

    PRINCIPAL INVESTIGATOR

  • Nanya Wang

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Liu

CONTACT

18840110641liuboliubo1109@163.com

Shangli Cai

CONTACT

86 021 61631938shangli.cai@brbiotech.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Gastroenterology & Hepatology

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

July 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 18, 2023

Record last verified: 2023-08

Locations

CN(2)