About this trial
It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Individuals who were diagnosed with either intrahepatic cholangiocarcinoma or hepatocellular carcinoma (case-case design for a differential diagnosis study)
Trial design
Case-only
Retrospective
Treatments tested in this trial
ELUCIDATE
Diagnostic testELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
Treatment groups
Trial outcomes
Primary outcomes
Sensitivity
True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
Secondary outcomes
Specificity
True Negative Rate: the probability of a negative test result, conditioned on the individual truly being negative
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Sponsors and contacts
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