Status:
COMPLETED
The CAROLE (CArdiac Related Oncologic Late Effects) Study
Lead Sponsor:
Northwell Health
Conditions:
Coronary Artery Disease
Cardiac Disease
Eligibility:
FEMALE
26-78 years
Brief Summary
CAROLE seeks to evaluate the relationship between chest Radiation Therapy and coronary artery disease. The purpose of CAROLE is to check the heart health of women who received breast cancer treatment...
Detailed Description
Background: Within the United States, there are an estimated 3.1 million women alive who have been diagnosed with invasive breast cancer, and approximately 56% of them have received radiation. Worldwi...
Eligibility Criteria
Inclusion
- If you are a breast cancer survivor who was diagnosed between the ages of ≥ 18-65 years (now at age 26-78).
- It has been at least 6 years since you were diagnosed.
- If you did not have a diagnosis of heart disease before\* having breast cancer.
- (\*women diagnosed with heart disease after breast cancer may still be eligible)
Exclusion
- Patients who are unable to care for themselves or who are unable to come in for testing due to health conditions or incarceration will be rescheduled or removed in the case of chronic ineligibility. No vulnerable patient populations will be used in this study. Patients will be excluded if they have any pre-existing cardiac disease at the time of diagnosis of their breast cancer (2004-2011).
- Pregnant and nursing women are ineligible.
Key Trial Info
Start Date :
June 27 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 26 2018
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03235427
Start Date
June 27 2017
End Date
June 26 2018
Last Update
May 21 2019
Active Locations (1)
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1
Northwell Health
Lake Success, New York, United States, 11042