NCT03628651

Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,150 (actual)
• Sponsor: Exact Sciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).

Detailed description

Subjects with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing HCC surveillance will be enrolled and have blood samples collected. Subjects undergoing HCC surveillance will be followed for up to 6 months. Another blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.

Conditions

• Hepatocellular Carcinoma
• Hepatocellular Carcinoma Surveillance

Interventions

Type	Name	Description
OTHER	Blood Sample Collection	HCC subjects will have one blood sample collected.
OTHER	Blood Sample Collection	Surveillance subjects will have a blood sample collected and will be followed for up to 6 months. A second blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.

Timeline

• Start date: 2018-04-02
• Primary completion: 2020-03-11
• Completion: 2020-03-11
• First posted: 2018-08-14
• Last updated: 2020-08-06

Locations

74 sites across 7 countries: United States, France, Germany, Italy, Spain, Taiwan, Thailand