Clinical trial NCT05996666: Primary Liver Cancer Early Detection
Official title: Early Detection of Primary Liver Cancer Based on cfDNA Methylation: A Multi-Center Case-Control Study (PRIMe-liver)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cancer
Keywords: Early detection
Liver cancer
cell-free DNA (cfDNA)
qPCR
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: Guangzhou Burning Rock Dx Co., Ltd.
First posted: 2023-08-18
Enrollment: 701
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants enrolled in this study included subjects with primary liver cancers, benign liver diseases, interfering cancers, and healthy individuals.

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.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for all participants

* Individuals aged 18-74 years old
* Individuals capable of giving signed and legally effective informed consent voluntarily

Inclusion Criteria for liver cancer participants:

* 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.

Inclusion Criteria for participants with benign liver diseases:

* Individuals newly diagnosed as benign liver diseases before blood sample collection
* Individuals without curative treatment for the disease before blood sample collection

Inclusion Criteria for participants with interfering cancers:

* Individuals diagnosed with or suspected of having interfering cancer
* Individuals without any anti-cancer therapy prior to blood sample collection

Inclusion Criteria for healthy participants:

* No cancer-related or other clinical symptoms 30 days prior to blood sample collection
* No prior history of benign liver diseases

Exclusion Criteria:

Exclusion Criteria for All the Participants:

* 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

Exclusion Criteria for liver cancer participants:

* Known prior or current diagnosis of other types of malignancies or multiple primary cancers
* No confirmed diagnosis of liver cancer after blood sample collection

Exclusion Criteria for participants with benign liver diseases:

* 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

Exclusion Criteria for participants with interfering cancers:

* 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

Exclusion Criteria for healthy participants:

* Prior or ongoing treatment of cancers within 3 years prior to blood sample collection
* Clinically significant or uncontrolled comorbidities

Primary outcomes:
measure: Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR
timeFrame: 2023.07.01-2023.12.30
Secondary outcomes:
measure: Performance of the liver cancer early detection model in detecting liver cancer at early stage
timeFrame: 2023.07.01-2023.12.30
measure: Performance of liver cancer early detection model in detecting liver cancer at different stages and subtypes
timeFrame: 2023.07.01-2023.12.30
measure: Performance of liver cancer early detection model to differentiate non-liver cancers
timeFrame: 2023.07.01-2023.12.30
measure: Comparison of currently used biomarkers for liver cancer detection
timeFrame: 2023.07.01-2023.12.30
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin university first hospital
state: Jilin
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Tian Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Nanya Wang
role: PRINCIPAL_INVESTIGATOR
References: