Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening

Hepatocellular Carcinoma Clinical Trial

Official title:

Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833298
• Other study ID #: GCO 16-1542
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: April 1, 2018

Study information

• Verified date: October 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• HCC
• HCV
• Hepatitis C
• Hepatocellular Carcinoma

Intervention

Behavioral:
• Automated reminders
At the time consent is obtained, members of the research team will collect data about how a subject prefers to be contacted for automated reminders (i.e. text messages, postcard, email, MyChart)
• Patient navigation
The patient navigator will attempt to provide a reminder to the subject one to three days before the scheduled imaging and also offer to accompany the subject to the test.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCC screening rates	Ratio of Number of on-time screening visits to number of missed screening visits	every 6 months until death - average of 5 years
Secondary	Adherence to HCC Surveillance	Percentage for patients completing timely screening visit	every 6 months until death - average of 5 years
Secondary	Rates of HCC	New incidences of HCC	every 6 months until death - average of 5 years
Secondary	Incidence of Death	Incidence of death	every 6 months until death - average of 5 years
Secondary	Incidence of liver transplant		every 6 months until death - average of 5 years