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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 weeks
Treatment ~ Varies
Follow Up ~treatment and outcomes data will be collected for up to 3 years post-enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment and outcomes data will be collected for up to 3 years post-enrollment. for reporting.

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.

Find a Location

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
~183 spots leftby Jan 2025