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Early detection of cardiovascular changes after radiotherapy for breast cancer : protocol for a european multicenter prospective cohort study (MEDIRAD EARLY HEART Study)

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dc.contributor.authorWalker, Valentin
dc.contributor.authorCrijns, Anne
dc.contributor.authorLangendijk, Johannes
dc.contributor.authorSpoor, Daan
dc.contributor.authorVliegenthart, Rozemarijn
dc.contributor.authorCombs, Stephanie E.
dc.contributor.authorMayinger, Michael
dc.contributor.authorEraso, Arantxa
dc.contributor.authorGuedea, Ferran
dc.contributor.authorFiuza, Manuela
dc.contributor.authorSantos, Susana Constantino Rosa
dc.contributor.authorTamarat, Radia
dc.contributor.authorLaurier, Dominique
dc.contributor.authorFerrières, Jean
dc.contributor.authorMousseaux, Elie
dc.contributor.authorCardis, Elisabeth
dc.contributor.authorJacob, Sophie
dc.date.accessioned2019-06-18T16:03:37Z
dc.date.available2019-06-18T16:03:37Z
dc.date.issued2018
dc.description© Valentin Walker, Anne Crijns, Johannes Langendijk, Daan Spoor, Rozemarijn Vliegenthart, Stephanie E Combs, Michael Mayinger, Arantxa Eraso, Ferran Guedea, Manuela Fiuza, Susana Constantino, Radia Tamarat, Dominique Laurier, Jean Ferrières, Elie Mousseaux, Elisabeth Cardis, Sophie Jacob. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.10.2018. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.pt_PT
dc.description.abstractBackground: Breast cancer is the most common cancer among women, and radiotherapy plays a major role in its treatment. However, breast cancer radiotherapy can lead to incidental irradiation of the heart, resulting in an increased risk for a variety of heart diseases arising many years after radiotherapy. Therefore, identifying breast cancer patients at the highest risk for radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy aging. There is still a need for precise knowledge on the relationship between radiation dose to specific cardiac structures and early subclinical cardiac changes and their occurrence over time that could finally lead to cardiac complications. Objective: The MEDIRAD EARLY HEART study aims to identify and validate new cardiac imaging and circulating biomarkers of radiation-induced cardiovascular changes arising within first 2 years of breast cancer radiotherapy and to develop risk models integrating these biomarkers combined with precise dose metrics of cardiac structures based on three-dimensional dosimetry. Methods: The EARLY HEART study is a multicenter, prospective cohort study in which 250 women treated for breast cancer and followed for 2 years after radiotherapy will be included. Women treated with radiotherapy without chemotherapy for a unilateral breast cancer and aged 40-75 years meet the inclusion criteria. Baseline and follow-up data include cardiac measurements based on two-dimensional speckle-tracking echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging, and a wide panel of circulating biomarkers of cardiac injury. The absorbed dose will be evaluated globally for the heart and different substructures. Furthermore, the dose-response relationship will allow modeling the radiation-induced occurrence and evolution of subclinical cardiac lesions and biomarkers to develop prediction models. Results: This study details the protocol of the MEDIRAD EARLY HEART study and presents the main limits and advantages of this international project. The inclusion of patients began in 2017. Preliminary results are expected to be published in 2019, and complete analysis should be published in 2021. Conclusions: The MEDIRAD EARLY HEART study will allow identifying the main cardiac imaging and blood-based determinants of radiation-induced cardiac injuries to better propose primary and secondary preventive measures in order to contribute to enhanced patient care and quality of life. Trial Registration: ClinicalTrials.gov NCT03297346; https://clinicaltrials.gov/ct2/show/NCT03297346 (Archived by WebCite at http://www.webcitation.org/72KS7MIUU) Registered Report Identifier: RR1-10.2196/9906pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationJMIR Res Protoc 2018;7(10):e178pt_PT
dc.identifier.doi10.2196/resprot.9906pt_PT
dc.identifier.issn1929-0748
dc.identifier.urihttp://hdl.handle.net/10451/38736
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherJMIR Publicationspt_PT
dc.relation.publisherversionhttps://www.researchprotocols.org/pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectBiomarkerspt_PT
dc.subjectBreast cancerpt_PT
dc.subjectCardiotoxicitypt_PT
dc.subjectCardiac diagnostic imagingpt_PT
dc.subjectRadiotherapypt_PT
dc.subjectRadiation dosimetrypt_PT
dc.titleEarly detection of cardiovascular changes after radiotherapy for breast cancer : protocol for a european multicenter prospective cohort study (MEDIRAD EARLY HEART Study)pt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue10pt_PT
oaire.citation.startPagee178pt_PT
oaire.citation.titleJMIR Research Protocolspt_PT
oaire.citation.volume7pt_PT
person.familyNameFiuza
person.familyNameConstantino Rosa Santos
person.givenNameManuela
person.givenNameSusana
person.identifier1814324
person.identifier.ciencia-idF11D-8C75-78BF
person.identifier.orcid0000-0002-7742-6195
person.identifier.orcid0000-0002-5711-1292
person.identifier.scopus-author-id6701659391
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublicationdb433720-8321-488c-ad7e-42e987b41375
relation.isAuthorOfPublicationbbd5fe87-d7bb-431a-8f61-37e86fd4d2f6
relation.isAuthorOfPublication.latestForDiscoverybbd5fe87-d7bb-431a-8f61-37e86fd4d2f6

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