Detecting liver cancer early using blood tests

Early Detection of Primary Liver Cancer Based on cfDNA Methylation: A Multi-Center Case-Control Study (PRIMe-liver)

This study is testing a new blood test to see if it can help find liver cancer early in people who have just been diagnosed with it or other liver issues.

Quick facts

• Study type: Observational
• Enrollment: 701 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (other)
• Locations: 2 sites (Changchun, Jilin and 1 other locations)
• Trial ID: NCT05996666 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish an early detection model for primary liver cancer by analyzing cell-free DNA (cfDNA) methylation biomarkers through qPCR. It builds on previous findings that demonstrated high sensitivity and specificity for liver cancer detection. Participants will include individuals newly diagnosed with liver cancer, benign liver diseases, or other cancers, all of whom will provide blood samples for analysis. The study seeks to validate the effectiveness of this non-invasive detection method across multiple centers.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18-74 who are newly diagnosed with or suspected of having liver cancer or benign liver diseases.

Not a fit: Patients who have already received anti-cancer therapy prior to blood sample collection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis of liver cancer, improving treatment outcomes and survival rates.

How similar studies have performed: Previous studies have shown promising results in early cancer detection using cfDNA methylation, indicating potential for success in this approach.

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

Where this trial is running

Changchun, Jilin and 1 other locations

• Jilin university first hospital — Changchun, Jilin, China (RECRUITING)
• Eastern Hepatobiliary Surgery Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Tian Yang — Eastern Hepatobiliary Surgery Hospital
• Study coordinator: Bo Liu

Conditions: Liver Cancer, Early detection, Liver cancer, cell-free DNA, qPCR