Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening
| Status: | Completed |
|---|---|
| Conditions: | Liver Cancer, Cancer, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/14/2018 |
| Start Date: | November 2016 |
| End Date: | April 1, 2018 |
Approximately half of the patients receiving treatment for chronic hepatitis C virus (HCV)
infection in the United States have advanced liver disease. Patients with advanced
fibrosis/cirrhosis who achieve a sustained virological response (SVR) to treatment and are
clinically cured of HCV continue to have an elevated risk of developing hepatocellular
carcinoma (HCC). According to guidelines from several professional societies and from the
American Association for the Study of Liver Diseases (AASLD), in particular, patients with
advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident HCC
whether they achieve an SVR, or not. The number of patients who need post-SVR HCC screening
has risen dramatically in recent years due to the confluence of three factors: Increased
screening for HCV, which has allowed more people to realize that they have this often
"silent" infection; the availability of safe and highly effective direct acting antiviral
drugs (DAAs) for HCV, which has allowed a much higher percentage of treated patients to
achieve an SVR; and the long duration of HCV infection in many patients, which has allowed
enough time for advanced fibrosis/cirrhosis to develop. To investigate post-SVR patients in
the era of DAAs and to promote HCC screening, the objective of this study is to conduct a
randomized, unblinded, two-arm prospective intervention trial comparing rates of HCC
screening between patients randomized to either personalized patient navigation or automated
reminders (e.g. electronic or mailed). Both interventions represent improved care over
current standard of care (no patient navigation or automated reminders). There is no evidence
to suggest one intervention is better than the other. Healthcare providers who agree to
participate in the study will be contacted to confirm the liver disease status of their
patients and during the clinical trial the providers of patients in both arms of the trial
will be sent reminders about the need to schedule patients for screening visits.
infection in the United States have advanced liver disease. Patients with advanced
fibrosis/cirrhosis who achieve a sustained virological response (SVR) to treatment and are
clinically cured of HCV continue to have an elevated risk of developing hepatocellular
carcinoma (HCC). According to guidelines from several professional societies and from the
American Association for the Study of Liver Diseases (AASLD), in particular, patients with
advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident HCC
whether they achieve an SVR, or not. The number of patients who need post-SVR HCC screening
has risen dramatically in recent years due to the confluence of three factors: Increased
screening for HCV, which has allowed more people to realize that they have this often
"silent" infection; the availability of safe and highly effective direct acting antiviral
drugs (DAAs) for HCV, which has allowed a much higher percentage of treated patients to
achieve an SVR; and the long duration of HCV infection in many patients, which has allowed
enough time for advanced fibrosis/cirrhosis to develop. To investigate post-SVR patients in
the era of DAAs and to promote HCC screening, the objective of this study is to conduct a
randomized, unblinded, two-arm prospective intervention trial comparing rates of HCC
screening between patients randomized to either personalized patient navigation or automated
reminders (e.g. electronic or mailed). Both interventions represent improved care over
current standard of care (no patient navigation or automated reminders). There is no evidence
to suggest one intervention is better than the other. Healthcare providers who agree to
participate in the study will be contacted to confirm the liver disease status of their
patients and during the clinical trial the providers of patients in both arms of the trial
will be sent reminders about the need to schedule patients for screening visits.
Inclusion Criteria:
- ≥21 years old
- history of HCV infection treated in 2011 or after with direct acting antiviral therapy
- achieved ≥SVR-12 as defined as no detectable virus 12 weeks or longer after the
cessation of therapy
- FIB-4 ≥3.25
- no history of HCC prior to treatment
- HCV provider deems a subject eligible for HCC surveillance according to AASLD criteria
- able to understand and speak English
- willing to sign the informed consent
- have a working phone number or e-mail to reach them
- no history of liver transplantation.
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