Detecting lymph node metastasis in liver cancer
An Exosome-based Liquid Biopsy Signature for Pre-operative Identification of Lymph Node Metastasis in Patients With Intrahepatic Cholangiocarcinoma
This study is trying to see if a blood test can better detect lymph node spread in patients with liver cancer before they start treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Duarte, California and 3 other locations) |
| Trial ID | NCT06381648 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a liquid biopsy assay to accurately detect lymph node metastasis (LNM) in patients with intrahepatic cholangiocarcinoma (ICC) before treatment. Given the poor prognosis associated with LNM, the study seeks to improve preoperative prediction methods beyond current imaging techniques, which often lack sensitivity. By analyzing blood-derived samples for specific biomarkers, the study hopes to provide a more reliable assessment of LNM, potentially guiding treatment strategies and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a histologically confirmed diagnosis of intrahepatic cholangiocarcinoma who can provide a blood sample before treatment.
Not a fit: Patients with synchronous intrahepatic cholangiocarcinoma and non-intrahepatic cholangiocarcinoma or those with secondary liver cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate preoperative assessments of lymph node involvement in ICC, allowing for better treatment planning.
How similar studies have performed: While there have been attempts to predict LNM using various scoring systems, this liquid biopsy approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Intrahepatic cholangiocarcinoma and non- Intrahepatic cholangiocarcinoma diagnosed at or before surgery * Secondary liver cancer
Where this trial is running
Duarte, California and 3 other locations
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
- Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University — Hokkaido, Sapporo, Japan (Recruiting)
- Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University — Fukuoka, Japan (Recruiting)
- Department of Surgery, 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.