Primary Liver Cancer Early Detection

Trial Title: Primary Liver Cancer Early Detection

NCT ID: NCT05996666

Condition: Liver Cancer

Conditions: Official terms:
Liver Neoplasms

Conditions: Keywords:
Early detection
Liver cancer
cell-free DNA (cfDNA)
qPCR

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Liver-cancer early detection test
Description: Blood collection and liver-cancer early detection test
Arm group label: Benign diseases arm
Arm group label: Healthy arm
Arm group label: Interfering cancer arm
Arm group label: Liver cancer arm

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.

Criteria for eligibility:

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

Sampling method: Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: 74 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Jilin university first hospital

Address:
City: Changchun
Country: China

Status: Recruiting

Contact:
Last name: Bo Liu

Facility:
Name: Eastern Hepatobiliary Surgery Hospital

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Lanqing Yao

Start date: July 1, 2023

Completion date: December 2023

Lead sponsor:
Agency: The First Hospital of Jilin University
Agency class: Other

Collaborator:
Agency: Guangzhou Burning Rock Dx Co., Ltd.
Agency class: Industry

Source: The First Hospital of Jilin University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05996666