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A Prospective Longitudinal Breast Cancer Study | Clinical Trials | Clareo Health

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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

NCT02270931•Fujirebio Diagnostics, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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

Locations (3)

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, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

June 30, 2021

Completion Date

June 30, 2021

Last Updated

August 17, 2021

Enrollment

130

ESTIMATED participants

Conditions

Breast Cancer

Interventions

CA 15-3 Assay

DEVICE

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Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Prospective Longitudinal Breast Cancer Study

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer