Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC

Completed

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT02436772
• Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary

This study evaluates the performance of a blood test for detecting biomarkers in metastatic breast cancer patients at one clinic against standard testing.

Detailed Description

The primary objective of this pilot study is to detect the expression of FGFR1 and AR on circulating tumor cells (CTCs) isolated from the peripheral blood of metastatic breast cancer (MBC) patients using the OncoCEE™ platform. No procedures will be associated with this study, as these mutations will be evaluated from the leftover blood that has already been sent for standard of care ER and HER2 using the same platform. Results from this testing will be correlated with results obtained from standard testing to calculate the rate of concordance between tests.

Study Timeline

• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-04
• Study First Posted: 2015-05-07
• Study Start: 2015-05-13
• Primary Completion: 2017-07-07
• Study Completion: 2017-07-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Current patient at participating clinic
• Metastatic breast cancer diagnosis
• 18 years of age or older

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance with standard test	6 months	determined by the comparison between OncoCEE test and conventional test

Trial Locations

Locations (1)

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States