Helio Health, LAM-2018-01, Hepatocellular Ca, IvyGene Dx Liver Cancer Test

Summary

Primary objectives: The primary objective of this study is to compare the performance (sensitivity and specificity) of ultrasound alone to the combination of both ultrasound and the IvyGene® Dx Liver Cancer Test for the detection of hepatocellular carcinoma within a high-risk population. The primary method to confirm or rule out the presence of hepatocellular carcinoma will be diagnostic imaging by using multiphasic MRI. Secondary objectives: The secondary objectives of this study are:1) To compare the performance (sensitivity and specificity) of ultrasound alone to the IvyGene® Dx Liver Cancer Test alone for the detection of hepatocellular carcinoma.2) To compare the performance (sensitivity and specificity) of ultrasound alone to the combination of both ultrasound and the IvyGene® Dx Liver Cancer Test for the detection of hepatocellular carcinoma lesions that are ≤ 2cm in diameter.3) To compare the performance (sensitivity and specificity) of ultrasound alone to the IvyGene® Dx Liver Cancer Test alone for the detection of hepatocellular carcinoma lesions that are ≤ 2cm in diameter.


Inclusion Criteria

  • Subject is age 21 to 84 (inclusive)
  • Subject is able to read, comprehend and sign the Informed Consent Document
  • Subject is willing and able to undergo liver cancer surveillance by ultrasound and the multi-analyte blood Test
  • Subject is able and willing to undergo diagnostic imaging by multiphasic MRI with contrast according to the Study Protocol
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Study Location(s)

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

Full Title

LAM-2018-01: Prospective Clinical Trial to Detect Liver Cancer through Quantification of cfDNA Methylation in Blood Samples

Details
Disease Type/Condition

Liver

Principal Investigator

Yang, Ju Dong

Co-Investigators

Juvelyn Palomique

Age Group

Adult

Phase

N/A (Cancer Control)

IRB Number

STUDY00001282

ClinicalTrials.gov ID

NCT03694600

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Liver

Principal Investigator

Yang, Ju Dong

Age Group

Adult

Phase

N/A (Cancer Control)

IRB Number

LAM-2018-01

ClinicalTrials.gov ID

NCT03694600

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?