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Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE)
This study is currently recruiting participants.
Verified July 2017 by Johannes A. Langendijk, University Medical Center Groningen
Sponsor:
University Medical Center Groningen
Collaborators:
Stichting het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Klinikum rechts der Isar der Technischen Universität München
Institut de Radioprotection et de Sûreté Nucléaire
Information provided by (Responsible Party):
Johannes A. Langendijk, University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT03211442
First received: July 6, 2017
Last updated: NA
Last verified: July 2017
History: No changes posted
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Purpose
MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac structures and the risk of acute coronary events (ACE) and other cardiac complications in breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue Complication Probability (NTCP) models to assess the risk of ACE in individual patients based on cardiac dose metrics in the first 10 years after BC radiotherapy.
| Condition | Intervention |
|---|---|
| Breast Cancer Female Acute Coronary Events Cardiac Complications | Radiation: Radiotherapy |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Johannes A. Langendijk, University Medical Center Groningen:
Primary Outcome Measures:
- Number of patients with an Acute Coronary Event after completion of RT treatment [ Time Frame: First 10 years after RT treatment ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 7000 |
| Anticipated Study Start Date: | August 2017 |
| Estimated Study Completion Date: | November 2019 |
| Estimated Primary Completion Date: | November 2019 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Radiation: Radiotherapy
Breast cancer patients treated with radiotherapy
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult, female patients with stage I-III breast cancer, treated with primary surgery, either by mastectomy of breast conserving surgery, and postoperative RT in the period 2005-2013, and who were aged 40-75 years at the time of RT
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211442
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211442
Contacts
| Contact: A.P.G. Crijns, Dr. | +31503615532 | a.p.g.crijns@umcg.nl |
Locations
| Netherlands | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands, 9700RB | |
| Contact: A.P.G. Crijns, Dr. +31503615532 a.p.g.crijns@umcg.nl | |
Sponsors and Collaborators
University Medical Center Groningen
Stichting het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Klinikum rechts der Isar der Technischen Universität München
Institut de Radioprotection et de Sûreté Nucléaire
More Information
| Responsible Party: | Johannes A. Langendijk, Prof.Dr., University Medical Center Groningen |
| ClinicalTrials.gov Identifier: | NCT03211442 History of Changes |
| Other Study ID Numbers: |
RT2017-08 |
| Study First Received: | July 6, 2017 |
| Last Updated: | July 6, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Johannes A. Langendijk, University Medical Center Groningen:
|
Breast cancer Radiotherapy Cardiac complications Acute coronary events NTCP model |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on July 11, 2017