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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
NCT02485626 |
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Date of registration:
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23/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors
HARBOR |
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Scientific title:
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HARBOR Study: Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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628 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02485626 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Flora E. van Leeuwen, Prof. dr. |
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Address:
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Telephone:
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Email:
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f.v.leeuwen@nki.nl |
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Affiliation:
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Name:
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Flora E. van Leeuwen, Prof. dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Netherlands Cancer Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- early invasive BC (TNM stage I - III);
- diagnosed and/or treated in the AVL or UMCG;
- treated 5 - 7 years or 10 - 12 years ago;
- aged 40-50 years at time of therapy;
- signed written informed consent.
Exclusion Criteria:
- history of RT or CT unrelated to BC;
- current treatment for BC recurrence or second malignancy (including contralateral BC)
with the exception of non-melanoma skin cancer or curatively treated carcinoma in
situ of the cervix;
- history of cardiac disease (CHF, acute coronary syndrome, coronary revascularization
procedure, symptomatic valvular dysfunction, cardiomyopathy or congenital heart
defect) before diagnosis and treatment for BC;
- mental disability or psychological condition potentially hampering compliance with
the study protocol;
- insufficient understanding of the Dutch language.
Age minimum:
40 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Cardiovascular Diseases
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Intervention(s)
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Procedure: 2D tissue doppler echocardiography
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Primary Outcome(s)
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Left ventricular ejection fraction
[Time Frame: up to 12 years after breast cancer diagnosis]
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Secondary Outcome(s)
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Diastolic cardiac function
[Time Frame: up to 12 years after breast cancer diagnosis]
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Intima media thickness and arterial stiffness
[Time Frame: up to 12 years after breast cancer diagnosis]
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Cardiac deformation
[Time Frame: up to 12 years after breast cancer diagnosis]
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Biomarker assessment
[Time Frame: up to 12 years after breast cancer diagnosis]
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Secondary ID(s)
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NL49405.031.14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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