Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE)
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ClinicalTrials.gov Identifier: NCT03211442 |
Recruitment Status :
Completed
First Posted : July 7, 2017
Last Update Posted : February 28, 2024
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Condition or disease | Intervention/treatment |
---|---|
Breast Cancer Female Acute Coronary Events Cardiac Complications | Radiation: Radiotherapy |
Study Type : | Observational |
Actual Enrollment : | 7000 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE): A Retrospective Cohort Study |
Actual Study Start Date : | August 1, 2017 |
Actual Primary Completion Date : | August 1, 2020 |
Actual Study Completion Date : | June 1, 2022 |
- Radiation: Radiotherapy
Breast cancer patients treated with radiotherapy
- Number of patients with an Acute Coronary Event after completion of RT treatment [ Time Frame: First 10 years after RT treatment ]
- Number of patients with other cardiac complications after completion of RT treatment [ Time Frame: First 10 years after RT treatment ]
- Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors) [ Time Frame: First 10 years after RT treatment ]
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Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Female breast cancer patients;
- Treated with primary surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS);
- Age between 40-75 years at time of start RT;
- WHO performance status 0-1;
- Planned for RT alone to the breast, the chest wall and/or the lymph node areas;
- Start of RT is between 01-01-2015 and 31-12-2013;
- Available planning CT scan and dose distribution;
- Adjuvant systemic treatment, including hormonal therapy or chemotherapy is allowed;
- Medical history of coronary artery disease and/or myocardial infarction is not an exclusion criterion;
- Written informed consent.
Exclusion Criteria:
- Male breast cancer patients;
- Women with metastatic breast cancer (M1 disease);
- Any prior malignancy other than non-melanoma skin cancer;
- Previous thoracic or mediastinal radiation;
- Women treated with neoadjuvant chemotherapy.
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): NCT03211442
Netherlands | |
University Medical Center Groningen | |
Groningen, Netherlands, 9700RB |
Responsible Party: | University Medical Center Groningen |
ClinicalTrials.gov Identifier: | NCT03211442 |
Other Study ID Numbers: |
RT2017-08 |
First Posted: | July 7, 2017 Key Record Dates |
Last Update Posted: | February 28, 2024 |
Last Verified: | February 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast cancer Radiotherapy Cardiac complications Acute coronary events NTCP model |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |