Primary Liver Cancer Early Detection

NCT ID: NCT05996666

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

701 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Liver cancer arm

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

Liver-cancer early detection test

Intervention Type DEVICE

Blood collection and liver-cancer early detection test

Benign diseases arm

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

Liver-cancer early detection test

Intervention Type DEVICE

Blood collection and 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.

Liver-cancer early detection test

Intervention Type DEVICE

Blood collection and liver-cancer early detection test

Interfering cancer arm

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

Liver-cancer early detection test

Intervention Type DEVICE

Blood collection and liver-cancer early detection test

Interventions

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Liver-cancer early detection test

Blood collection and liver-cancer early detection test

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou Burning Rock Dx Co., Ltd.

INDUSTRY

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Guoyue Lv

Professor of Gastroenterology & Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tian Yang

Role: PRINCIPAL_INVESTIGATOR

Eastern Hepatobiliary Surgery Hospital

Nanya Wang

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

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Jilin university first hospital

Changchun, Jilin, China

Site Status RECRUITING

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bo Liu

Role: CONTACT

18840110641

Shangli Cai

Role: CONTACT

86 021 61631938

Facility Contacts

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Bo Liu

Role: primary

Lanqing Yao

Role: primary

Other Identifiers

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RSCD2022015P

Identifier Type: -

Identifier Source: org_study_id

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