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Diagnostic Test
CT/MRI Surveillance Group for Hepatitis B
N/A
Recruiting
Led By Binu John
Research Sponsored by Exact Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment and outcomes data will be collected for up to 3 years post-enrollment.
Awards & highlights
Summary
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
Eligible Conditions
- Hepatitis B
- Liver Cancer
- Liver Cirrhosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment and outcomes data will be collected for up to 3 years post-enrollment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment and outcomes data will be collected for up to 3 years post-enrollment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Other outcome measures
Overall and early-stage sensitivity as well as specificity of ultrasound
Trial Design
2Treatment groups
Experimental Treatment
Group I: Ultrasound Surveillance GroupExperimental Treatment3 Interventions
Subjects will undergo standard of care ultrasound surveillance imaging. Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up with CT or MRI as well as other procedures as needed. Subjects with negative ultrasound will be sent for a study CT/MRI.
Group II: CT/MRI Surveillance GroupExperimental Treatment2 Interventions
Subjects will undergo standard of care CT/MRI surveillance imaging.
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Who is running the clinical trial?
Exact Sciences CorporationLead Sponsor
33 Previous Clinical Trials
257,040 Total Patients Enrolled
Binu JohnPrincipal InvestigatorMiami VA Healthcare System
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