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RecruitingNCT06342414

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

Sponsor

City of Hope Medical Center

Enrollment

400 participants

Start Date

Mar 15, 2024

Study Type

OBSERVATIONAL

Conditions

CholangiocarcinomaHepatocellular CarcinomaHepatic CarcinomaIntrahepatic CholangiocarcinomaHepatic CancerPrimary Liver CancerPrimary Liver Carcinoma

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

Interventions

DIAGNOSTIC_TESTELUCIDATE

ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)

Locations(5)

City of Hope Medical Center

Duarte, California, United States

Graduate School of Medical Sciences, Kyushu University

Fukuoka, Japan

Graduate School of Medical Sciences, Kumamoto University

Kumamoto, Japan

Hokkaido University Graduate School of Medicine

Sapporo, Japan

Tokushima University

Tokushima, Japan

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NCT06342414

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