Exosome-Based Liquid Biopsy for Liver Cancer
(ELUCIDATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to develop a blood test to help doctors determine whether a patient has hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC). By analyzing tiny particles in the blood called exosomes and using machine learning, researchers hope to better distinguish these two cancers before surgery. Individuals with a confirmed diagnosis of either HCC or ICC, who have undergone standard diagnostic procedures and have a blood sample available, might be suitable candidates for this trial. As an unphased trial, this study offers patients the opportunity to contribute to groundbreaking research that could enhance cancer diagnosis methods.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this liquid biopsy method is safe for differentiating liver cancers?
Research shows that ELUCIDATE, the treatment under study, is still in the early stages of testing for diagnosing liver cancer. Clear information on its safety is currently limited. However, as this study focuses on developing a diagnostic tool rather than a drug or invasive treatment, the risks are likely lower.
For treatments in early trials, safety information is often limited. In early phases, researchers closely monitor for safety and any side effects. If ELUCIDATE had been approved for another condition, it might suggest some level of safety, but no such approval is mentioned here.
Prospective participants should know that researchers prioritize participant safety and will provide detailed information about any potential risks before enrollment.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores an innovative method for diagnosing primary liver cancers, specifically hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), using an exosome-based liquid biopsy. Unlike traditional methods, which often require invasive tissue biopsies, this approach aims to detect cancer-related biomarkers in the blood. This non-invasive technique could potentially offer quicker, safer, and more convenient diagnosis for patients. Moreover, it might help differentiate between types of liver cancer more accurately, leading to more personalized treatment plans.
What evidence suggests that this liquid biopsy is effective for differentiating liver cancers?
Research shows that ELUCIDATE is being developed to differentiate between two types of primary liver cancer: intrahepatic cholangiocarcinoma (ICC) and hepatocellular carcinoma (HCC). The trial includes separate cohorts for ICC and HCC to evaluate ELUCIDATE's effectiveness in distinguishing these cancers. This distinction is crucial because ICC is a rare and aggressive cancer, with only about 30-35% of patients surviving five years post-surgery. Machine learning models have shown promise in predicting survival outcomes for ICC, which might be similar to ELUCIDATE's function.
For HCC, early detection through regular check-ups can lead to better outcomes, allowing treatments to start sooner and potentially increasing survival rates. Although ELUCIDATE is primarily a diagnostic tool, improving the ability to distinguish these cancers could lead to more targeted treatments and better outcomes for patients.678910Who Is on the Research Team?
Ajay Goel, PhD
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
RNA Sequencing
Comprehensive small RNA-Seq from exo-miRNA from patients with ICC and HCC
Model Development
Develop and train a differential diagnosis panel using machine-learning models
Validation
Validate the findings in an independent cohort of ICC and HCC
Follow-up
Participants are monitored for safety and effectiveness after the study
What Are the Treatments Tested in This Trial?
Interventions
- ELUCIDATE
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)
A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)
A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)
A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
Citations
Hepatocellular Carcinoma Surveillance Patterns and ...
Hepatocellular carcinoma (HCC) surveillance is associated with improved early detection and reduced mortality, although practice patterns and effectiveness vary ...
Hepatocellular carcinoma: signaling pathways and ...
While the two trials showing discouraging results with limited efficacy and severe adverse effects. Though a phase I/II study failed ...
Cost-Effectiveness of Hepatocellular Carcinoma ...
GAAD + US was the most clinically effective strategy, with the highest rate of early-stage HCC detection (58%), followed by GAAD alone (48%), US + AFP (45%) and ...
Outcomes of Hepatocellular Carcinoma Patients Treated ...
In both cases, median survivals were significantly higher (Log-rank p < 0.001) than the pooled median of 5.7 months (95% CI: 4.5–6.7) already calculated for ...
Outcomes of hepatocellular carcinoma by etiology with first ...
The median overall survival for the entire cohort was 9.4 months (95% CI 7.1–10.9). Compared with Viral-HCC, the hazard ratio (HR) of death was ...
Hepatocellular Carcinoma Etiology Drives Survival Outcomes
The prognosis of HCC is poor with a US 5-year relative survival of only 21.6% for 2013–2019 from SEER. HCC prognosis is affected by a complex array of factors ...
Hepatocellular Carcinoma Surveillance Patterns and ...
Hepatocellular carcinoma (HCC) surveillance is associated with improved early detection and reduced mortality, although practice patterns and effectiveness vary ...
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acsjournals.onlinelibrary.wiley.com
acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.31066Effect of hospital safety net designation on treatment use and ...
Similarly, patients with localized HCC were less likely to undergo curative treatment at h-SNHs than non-SNHs (OR, 0.51; 95% CI, 0.40-0.66).
A global view of hepatocellular carcinoma: trends, risk ...
Risk factors for HCC include chronic hepatitis B and hepatitis C, alcohol addiction, metabolic liver disease (particularly nonalcoholic fatty liver disease) ...
Articles Socioeconomic inequalities in diagnostics, care ...
A total of 1905 patients (35%) were diagnosed with early-stage HCC. Patients with high and medium household incomes were more often diagnosed at early stages ...
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