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The CAROLE (CArdiac Related Oncologic Late Effects) Study (CAROLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03235427
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Lucille Lee, Northwell Health

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 treatments in the past and protect them from future heart disease.


Condition or disease
Coronary Artery Disease Cardiac Disease Cardiac Toxicity Radiation Radiation Therapy Atherosclerotic Heart Disease Cardiotoxicity Breast Cancer Lung Cancer Lymphoma Cancer Carcinoma, Intraductal, Noninfiltrating

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 201 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The CAROLE (CArdiac Related Oncologic Late Effects) Study
Actual Study Start Date : June 27, 2017
Actual Primary Completion Date : June 26, 2018
Actual Study Completion Date : June 26, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Received Radiation Therapy(RT)
Patients who had received radiotherapy will be sub-stratified into those who received treatment to the left or right breast.
Did not receive Radiation Therapy (RT)
Patients who did not receive radiation treatment, but received chemotherapy, hormonal therapy, and/or surgery will be used as study controls to compare the prevalence and burden of cardiac disease as compared to radiation patients.



Primary Outcome Measures :
  1. Multimodality Cardiology Assessment- EKG [ Time Frame: 1 Year ]

    Assess whether radiation to the heart is associated with increased pre-clinical and clinical cardiac disease (as determined by a composite of multimodality cardiology assessments including EKG.

    Studies will be read using a standard, evidence based, set of criterion and documented using study templates) and compared to patients who did not receive radiation to the heart.

    All cardiac tests will be reviewed and reported as a composite with one the following; No evidence of disease/unrelated, preclinical disease, or clinical disease (non-numerically) based on the Cardiologists read of the study based on standard Pre-Specified criteria.


  2. Multimodality Cardiology Assessment- Echocardiogram with Strain [ Time Frame: 1 Year ]

    Assess whether radiation to the heart is associated with increased pre-clinical and clinical cardiac disease (as determined by a composite of multimodality cardiology assessments including Echocardiogram with Strain.

    All cardiac tests will be reviewed and reported as a composite with one the following; No evidence of disease/unrelated, preclinical disease, or clinical disease (non-numerically) based on the Cardiologists read of the study based on standard Pre-Specified criteria.


  3. Multimodality Cardiology Assessment- Coronary Artery Calcium (CAC) CT [ Time Frame: 1 Year ]

    Assess whether radiation to the heart is associated with increased pre-clinical and clinical cardiac disease (as determined by a composite of multimodality cardiology assessments including Coronary Artery Calcium (CAC) CT.

    All cardiac tests will be reviewed and reported as a composite with one the following; No evidence of disease/unrelated, preclinical disease, or clinical disease (non-numerically) based on the Cardiologists read of the study based on standard Pre-Specified criteria.



Secondary Outcome Measures :
  1. Agatston Score [ Time Frame: 1 Year ]

    Individual cardiac structures will be accessed using Agatston score. Agatston score is calculated using a CAC CT scan to measure for the presence of coronary artery disease based on the extent of coronary artery calcification. Specifically the left main, left anterior descending, left circumflex, and right coronary arteries are all read individually and the sum of these cardiac vessels scores is read as the overall Agatston score.

    Grading of coronary artery disease (based on total calcium score) measure is without units. Score categories are as follows: No evidence of disease/unrelated, preclinical disease, or clinical disease (non-numerically). Higher Agatston score correlates with more coronary artery disease.

    The assessment of calcium (Agatston score) on CAC CT will be compared to the dose received by the specified vessel as determined using deformable registration with prior radiation imaging (simulation CT scan).



Other Outcome Measures:
  1. Composite Assessment of Cardiac Disease [ Time Frame: 1 Year ]
    Sub-analysis for association of specific oncologic treatment(s) with cardiac disease (as per previously described study templates) will also be performed on patients who received multimodality treatment (RT+ chemotherapy, RT + hormonal treatment, RT+ chemo and hormonal treatment, RT + individual cardio toxic chemotherapies [anthracycline, trastuzumab, etc.]) and on different surgical approaches (lumpectomy and mastectomy). Results will be reported as a single value for each arm/group.



Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women aged 18-65 at the time of breast cancer diagnosis, with a minimum of 6 years since diagnosis, with no history of heart disease prior to participants breast cancer diagnosis.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235427


Locations
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United States, New York
Northwell Health
Lake Success, New York, United States, 11042
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Lucille Lee, MD Northwell Health
Principal Investigator: Lindsay L Puckett, MD Northwell Health

Publications:

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Responsible Party: Lucille Lee, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT03235427     History of Changes
Other Study ID Numbers: IIS-0046
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lucille Lee, Northwell Health:
Coronary
Coronary Disease
Coronary Arteriosclerosis
Heart Disease
Coronary Vessels
Coronary Artery Disease
Cardiac toxicity
Cardiac calcium score
Cardiac CT Scan
Coronary Artery
Coronary arteries
Cardiac Side Effect
Cardiac tissue
Cardiac
Cardiotoxicity
Breast Cancer
Carcinoma
Radiation
Radiation Therapy
CAD
RT
CT
Chest RT
Lung Cancer
Lymphoma

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Chemically-Induced Disorders
Cardiotoxicity
Carcinoma, Intraductal, Noninfiltrating
Arteriosclerosis
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Radiation Injuries
Wounds and Injuries
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Breast Carcinoma In Situ
Carcinoma in Situ
Neoplasms, Ductal, Lobular, and Medullary