Status:
UNKNOWN
Primary Liver Cancer Early Detection
Lead Sponsor:
The First Hospital of Jilin University
Collaborating Sponsors:
Guangzhou Burning Rock Dx Co., Ltd.
Conditions:
Liver Cancer
Eligibility:
All Genders
18-74 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
701 Patients enrolled
Trial Details
Trial ID
NCT05996666
Start Date
July 1 2023
End Date
December 1 2023
Last Update
August 18 2023
Active Locations (2)
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1
Jilin university first hospital
Changchun, Jilin, China
2
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China