Clinical trial NCT02270931: A Prospective Longitudinal Breast Cancer Study
Official title: A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fujirebio Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 130 subjects will be enrolled in this study. Women and men greater than or equal to 18 years of age with a histologically/pathologically confirmed diagnosis of breast cancer and a minimum of three serial blood draws collected at disease evaluation time points, as determined by the treating physician's standard of care, will be eligible.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure CA 15-3 in Breast Cancer Patients
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Jane Skelton, MD
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
Study officials:
affiliation: Fujirebio Diagnostics, Inc.
name: Diana Dickson
role: STUDY_DIRECTOR
References: