An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • ELUCIDATE

    Diagnostic test

    ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Hepatocellular Carcinoma (Training)1 intervention
Group B: Intrahepatic Cholangiocarcinoma (Training)1 intervention
Group C: Hepatocellular Carcinoma (Validation)1 intervention
Group D: Intrahepatic Cholangiocarcinoma (Validation)1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity

True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Specificity

True Negative Rate: the probability of a negative test result, conditioned on the individual truly being negative

Time frame
Through study completion, an average of 1 year
2

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

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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