A Prospective Longitudinal Breast Cancer Study

Breast Cancer Clinical Trial

Official title:

A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270931
• Other study ID #: FDI-69
• Status: Completed
• Start date: May 2014
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2020
• Source: Fujirebio Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• CA 15-3 Assay
Physicians use the CA 15-3 test result to manage their patients

Locations

Country	Name	City	State
United States	Jane Skelton, MD	Boca Raton	Florida
United States	Broward Health Medical Center	Fort Lauderdale	Florida
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Fujirebio Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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