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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02270931

Enrollment

130

Registered

2014-10-22

Start date

2014-05-31

Completion date

2021-06-30

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DEVICECA 15-3 Assay

Physicians use the CA 15-3 test result to manage their patients

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Measure CA 15-3 in Breast Cancer Patients	3 years	130 patients with Recurrence or Progressive Breast Cancer.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026