This trial is active, not recruiting.

Condition breast cancer
Treatment ca 15-3 assay
Sponsor Fujirebio Diagnostics, Inc.
Start date May 2014
End date May 2017
Trial size 130 participants
Trial identifier NCT02270931, FDI-69


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure CA 15-3 in Breast Cancer Patients
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Males and females, age≥ 18 years - Histologic/pathologic confirmation of breast cancer - Any stage of disease: Newly diagnosed, stable, disease progression, surveillance - Any treatment time point: Treatment naïve, currently receiving or completed therapy for breast cancer including active monitoring. - Individuals with a history of malignant disease other than breast cancer that was resected greater than 5 years ago and are currently in remission are eligible. - Able to understand and willing to provide informed consent Exclusion Criteria: - Males and females, age <18 years - No histologic/pathologic confirmation of breast cancer - Any concurrent malignancy other than basal or squamous cell skin cancers, in-situ cervical cancer, or breast cancer. - Treatment plan with fewer than three visits expected in 3 years' time - Unable to provide informed consent

Additional Information

Official title A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Fujirebio Diagnostics, Inc..