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
1 other identifier
observational
130
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2014
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 17, 2021
July 1, 2020
7.2 years
October 2, 2014
August 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Measure CA 15-3 in Breast Cancer Patients
130 patients with Recurrence or Progressive Breast Cancer.
3 years
Interventions
Physicians use the CA 15-3 test result to manage their patients
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Jane Skelton, MD
Boca Raton, Florida, 33486, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402, United States
Biospecimen
Serum and Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Diana Dickson
Fujirebio Diagnostics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 22, 2014
Study Start
May 1, 2014
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
August 17, 2021
Record last verified: 2020-07