Liquid biopsy to differentiate types of primary liver cancer
An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer
City of Hope Medical Center · NCT06342414
This study is testing a new blood test to see if it can tell the difference between two types of liver cancer, hepatocellular carcinoma and intrahepatic cholangiocarcinoma, to help doctors diagnose patients more safely.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center (other) |
| Locations | 5 sites (Duarte, California and 4 other locations) |
| Trial ID | NCT06342414 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a non-invasive liquid biopsy that analyzes exosomal microRNAs to differentiate between hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). By utilizing machine learning and bioinformatics, the researchers seek to create a cost-effective and sensitive assay that can provide accurate diagnoses before surgical intervention. The study will involve patients with histologically confirmed diagnoses of either HCC or ICC, who have provided blood samples prior to treatment. This approach addresses the clinical need for a safer diagnostic method compared to traditional invasive tissue sampling.
Who should consider this trial
Good fit: Ideal candidates include patients with a confirmed diagnosis of either hepatocellular carcinoma or intrahepatic cholangiocarcinoma who have provided a blood sample.
Not a fit: Patients with synchronous hepatocellular carcinoma and intrahepatic cholangiocarcinoma or those with other types of primary or secondary liver cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly improve the accuracy of liver cancer diagnoses, leading to better-targeted treatments and improved patient outcomes.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer diagnosis, but this specific approach focusing on exosomal microRNAs for liver cancer differentiation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A histologically confirmed diagnosis of hepatocellular carcinoma * A histologically confirmed diagnosis of intrahepatic cholangiocarcinoma * Received standard diagnostic and staging procedures as per local guidelines * Availability of at least one blood-derived sample, drawn before receiving any curative-intent treatment Exclusion Criteria: * Lack of or inability to provide informed consent * Synchronous hepatocellular carcinoma and intrahepatic cholangiocarcinoma * Primary liver cancer other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma * Secondary liver cancer
Where this trial is running
Duarte, California and 4 other locations
- City of Hope Medical Center — Duarte, California, United States (RECRUITING)
- Graduate School of Medical Sciences, Kyushu University — Fukuoka, Japan (RECRUITING)
- Graduate School of Medical Sciences, Kumamoto University — Kumamoto, Japan (RECRUITING)
- Hokkaido University Graduate School of Medicine — Sapporo, Japan (RECRUITING)
- Tokushima University — Tokushima, Japan (RECRUITING)
Study contacts
- Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
- Study coordinator: Ajay Goel, PhD
- Email: AJGOEL@COH.ORG
- Phone: 6262183452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma, Primary Liver Cancer, Primary Liver Carcinoma, Hepatic Cancer, Hepatic Carcinoma, Exosome