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Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Validation) for Bile Duct Cancer (LyMIC Trial)
N/A
Recruiting
Led By Ajay Goel, PhD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
LyMIC Trial Summary
Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC. This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients.
Eligible Conditions
- Bile Duct Cancer
- Intrahepatic Cholangiocarcinoma
- Cholangiocarcinoma
- Liver Cancer
LyMIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sensitivity
Secondary outcome measures
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
Specificity
LyMIC Trial Design
4Treatment groups
Experimental Treatment
Group I: Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Validation)Experimental Treatment1 Intervention
Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort.
Group II: Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Training)Experimental Treatment1 Intervention
Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort.
Group III: Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Validation)Experimental Treatment1 Intervention
Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort.
Group IV: Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Training)Experimental Treatment1 Intervention
Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort.
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Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
568 Previous Clinical Trials
1,924,460 Total Patients Enrolled
Ajay Goel, PhDPrincipal InvestigatorCity of Hope Medical Center
9 Previous Clinical Trials
7,377 Total Patients Enrolled
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