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NCT02436772 Clinical Trial

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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02436772
Other study ID # SCRI HEOR_05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 13, 2015
Est. completion date July 7, 2017

Study information
Verified date September 2020
Source SCRI Development Innovations, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date July 7, 2017
Est. primary completion date July 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Current patient at participating clinic

- Metastatic breast cancer diagnosis

- 18 years of age or older

Exclusion Criteria:

None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Tennessee Oncology Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
SCRI Development Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concordance with standard test determined by the comparison between OncoCEE test and conventional test 6 months
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