Trials / Completed
CompletedNCT02270931
A Prospective Longitudinal Breast Cancer Study
A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 130 (estimated)
- Sponsor
- Fujirebio Diagnostics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of breast cancer.
Detailed description
The study objectives are described below: 1. Obtain serum and plasma specimens longitudinally collected from a minimum of 130 subjects diagnosed with breast cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 15-3 assays, currently under development, as an aid for monitoring recurrence or progressive disease. 2. To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 15-3 assays, for monitoring the course of disease and therapy in subjects diagnosed with breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CA 15-3 Assay | Physicians use the CA 15-3 test result to manage their patients |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
- First posted
- 2014-10-22
- Last updated
- 2021-08-17
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02270931. Inclusion in this directory is not an endorsement.