Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT05996666
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT05996666
Study Brief:
Protocol Section:
NCT05996666