Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study.
Identifieur interne : 002166 ( PubMed/Checkpoint ); précédent : 002165; suivant : 002167Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study.
Auteurs : David J. Pulford [Royaume-Uni] ; Philipp Harter [Allemagne] ; Anne Floquet [France] ; Catherine Barrett [Royaume-Uni] ; Dong Hoon Suh [Corée du Sud] ; Michael Friedlander [Australie] ; José Angel Arranz [Espagne] ; Kosei Hasegawa [Japon] ; Hiroomi Tada [États-Unis] ; Peter Vuylsteke [Belgique] ; Mansoor R. Mirza [Danemark] ; Nicoletta Donadello [Italie] ; Giovanni Scambia [Italie] ; Toby Johnson [Royaume-Uni] ; Charles Cox [Royaume-Uni] ; John K. Chan [États-Unis] ; Martin Imhof [Autriche] ; Thomas J. Herzog [États-Unis] ; Paula Calvert [Irlande (pays)] ; Pauline Wimberger [Allemagne] ; Dominique Berton-Rigaud [France] ; Myong Cheol Lim [Corée du Sud] ; Gabriele Elser [Allemagne] ; Chun-Fang Xu [Royaume-Uni] ; Andreas Du Bois [Allemagne]Source :
- BMC medical ethics [ 1472-6939 ] ; 2016.
Descripteurs français
- KwdFr :
- MESH :
- diagnostic : Tumeurs de l'ovaire.
- génétique : Protéine BRCA1, Tumeurs de l'ovaire.
- éthique : Divulgation.
- Accès à l'information, Consentement libre et éclairé, Femelle, Humains, Mutation, Pronostic, Préférence du patient.
English descriptors
- KwdEn :
- MESH :
- chemical , genetics : BRCA1 Protein.
- diagnosis : Ovarian Neoplasms.
- ethics : Disclosure.
- genetics : Ovarian Neoplasms.
- Access to Information, Female, Humans, Informed Consent, Mutation, Patient Preference, Prognosis.
Abstract
The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients.
DOI: 10.1186/s12910-016-0144-y
PubMed: 27769273
Affiliations:
- Allemagne, Australie, Autriche, Belgique, Corée du Sud, Danemark, Espagne, France, Irlande (pays), Italie, Japon, Royaume-Uni, États-Unis
- Aquitaine, Californie, Communauté de Madrid, District de Dresde, Hovedstaden, Latium, Nouvelle-Aquitaine, Ohio, Pennsylvanie, Province du Brabant wallon, Région wallonne, Saxe (Land), Vienne (Autriche)
- Bordeaux, Copenhague, Dresde, Louvain-la-Neuve, Madrid, Philadelphie, Rome, Vienne (Autriche)
- Université catholique de Louvain
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:27769273Le document en format XML
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<author><name sortKey="Du Bois, Andreas" sort="Du Bois, Andreas" uniqKey="Du Bois A" first="Andreas" last="Du Bois">Andreas Du Bois</name>
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<author><name sortKey="Harter, Philipp" sort="Harter, Philipp" uniqKey="Harter P" first="Philipp" last="Harter">Philipp Harter</name>
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<author><name sortKey="Friedlander, Michael" sort="Friedlander, Michael" uniqKey="Friedlander M" first="Michael" last="Friedlander">Michael Friedlander</name>
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<author><name sortKey="Arranz, Jose Angel" sort="Arranz, Jose Angel" uniqKey="Arranz J" first="José Angel" last="Arranz">José Angel Arranz</name>
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<author><name sortKey="Hasegawa, Kosei" sort="Hasegawa, Kosei" uniqKey="Hasegawa K" first="Kosei" last="Hasegawa">Kosei Hasegawa</name>
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<author><name sortKey="Tada, Hiroomi" sort="Tada, Hiroomi" uniqKey="Tada H" first="Hiroomi" last="Tada">Hiroomi Tada</name>
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<author><name sortKey="Vuylsteke, Peter" sort="Vuylsteke, Peter" uniqKey="Vuylsteke P" first="Peter" last="Vuylsteke">Peter Vuylsteke</name>
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<country xml:lang="fr">Belgique</country>
<wicri:regionArea>BGOG and Medical Oncology, Université Catholique de Louvain, CHU UCL Namur</wicri:regionArea>
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<country xml:lang="fr">Danemark</country>
<wicri:regionArea>NSGO and Rigshospitalet, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
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<affiliation wicri:level="1"><nlm:affiliation>MaNGO and Ospedale Filippo del Ponte, Varese, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>MaNGO and Ospedale Filippo del Ponte, Varese</wicri:regionArea>
<wicri:noRegion>Varese</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Scambia, Giovanni" sort="Scambia, Giovanni" uniqKey="Scambia G" first="Giovanni" last="Scambia">Giovanni Scambia</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Woman Health, MITO and Catholic University of the Sacred Heart, Rome, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Woman Health, MITO and Catholic University of the Sacred Heart, Rome</wicri:regionArea>
<placeName><settlement type="city">Rome</settlement>
<region nuts="2">Latium</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Johnson, Toby" sort="Johnson, Toby" uniqKey="Johnson T" first="Toby" last="Johnson">Toby Johnson</name>
<affiliation wicri:level="1"><nlm:affiliation>GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY</wicri:regionArea>
<wicri:noRegion>SG1 2NY</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Cox, Charles" sort="Cox, Charles" uniqKey="Cox C" first="Charles" last="Cox">Charles Cox</name>
<affiliation wicri:level="1"><nlm:affiliation>GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY</wicri:regionArea>
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</author>
<author><name sortKey="Chan, John K" sort="Chan, John K" uniqKey="Chan J" first="John K" last="Chan">John K. Chan</name>
<affiliation wicri:level="2"><nlm:affiliation>Palo Alto Medical Foundation, San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Palo Alto Medical Foundation, San Francisco, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Imhof, Martin" sort="Imhof, Martin" uniqKey="Imhof M" first="Martin" last="Imhof">Martin Imhof</name>
<affiliation wicri:level="3"><nlm:affiliation>Karl Landsteiner Research Institute and Department of Obstetrics and Gynecology, General Public Teaching Hospital, Korneuburg, Vienna, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Karl Landsteiner Research Institute and Department of Obstetrics and Gynecology, General Public Teaching Hospital, Korneuburg, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Herzog, Thomas J" sort="Herzog, Thomas J" uniqKey="Herzog T" first="Thomas J" last="Herzog">Thomas J. Herzog</name>
<affiliation wicri:level="2"><nlm:affiliation>NYGOG and University of Cincinnati Cancer Institute, Cincinnati, OH, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>NYGOG and University of Cincinnati Cancer Institute, Cincinnati, OH</wicri:regionArea>
<placeName><region type="state">Ohio</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Calvert, Paula" sort="Calvert, Paula" uniqKey="Calvert P" first="Paula" last="Calvert">Paula Calvert</name>
<affiliation wicri:level="1"><nlm:affiliation>Cancer Trials Ireland, 60 Fitzwilliam Square N, Dublin 2, Ireland.</nlm:affiliation>
<country xml:lang="fr">Irlande (pays)</country>
<wicri:regionArea>Cancer Trials Ireland, 60 Fitzwilliam Square N, Dublin 2</wicri:regionArea>
<wicri:noRegion>Dublin 2</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wimberger, Pauline" sort="Wimberger, Pauline" uniqKey="Wimberger P" first="Pauline" last="Wimberger">Pauline Wimberger</name>
<affiliation wicri:level="3"><nlm:affiliation>AGO Germany and Department of Gynecology and Obstetrics, TU Dresden, Carl-Gustav-Carus University, Dresden, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>AGO Germany and Department of Gynecology and Obstetrics, TU Dresden, Carl-Gustav-Carus University, Dresden</wicri:regionArea>
<placeName><region type="land" nuts="1">Saxe (Land)</region>
<region type="district" nuts="2">District de Dresde</region>
<settlement type="city">Dresde</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Berton Rigaud, Dominique" sort="Berton Rigaud, Dominique" uniqKey="Berton Rigaud D" first="Dominique" last="Berton-Rigaud">Dominique Berton-Rigaud</name>
<affiliation wicri:level="1"><nlm:affiliation>GINECO and ICO Centre René Gauducheau, Saint-Herblain, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>GINECO and ICO Centre René Gauducheau, Saint-Herblain</wicri:regionArea>
<wicri:noRegion>Saint-Herblain</wicri:noRegion>
<wicri:noRegion>Saint-Herblain</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lim, Myong Cheol" sort="Lim, Myong Cheol" uniqKey="Lim M" first="Myong Cheol" last="Lim">Myong Cheol Lim</name>
<affiliation wicri:level="1"><nlm:affiliation>KGOG, Gynecologic Cancer Branch and Center for Uterine Cancer, National Cancer Center, Goyang, Korea.</nlm:affiliation>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>KGOG, Gynecologic Cancer Branch and Center for Uterine Cancer, National Cancer Center, Goyang</wicri:regionArea>
<wicri:noRegion>Goyang</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Elser, Gabriele" sort="Elser, Gabriele" uniqKey="Elser G" first="Gabriele" last="Elser">Gabriele Elser</name>
<affiliation wicri:level="1"><nlm:affiliation>AGO Study Group, Wiesbaden, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>AGO Study Group, Wiesbaden</wicri:regionArea>
<wicri:noRegion>Wiesbaden</wicri:noRegion>
<wicri:noRegion>Wiesbaden</wicri:noRegion>
<wicri:noRegion>Wiesbaden</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Xu, Chun Fang" sort="Xu, Chun Fang" uniqKey="Xu C" first="Chun-Fang" last="Xu">Chun-Fang Xu</name>
<affiliation wicri:level="1"><nlm:affiliation>GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY</wicri:regionArea>
<wicri:noRegion>SG1 2NY</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Du Bois, Andreas" sort="Du Bois, Andreas" uniqKey="Du Bois A" first="Andreas" last="Du Bois">Andreas Du Bois</name>
<affiliation wicri:level="1"><nlm:affiliation>AGO Study group and Department of Gynecology & Gynecologic Oncology, Kliniken Essen Mitte (KEM), Essen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>AGO Study group and Department of Gynecology & Gynecologic Oncology, Kliniken Essen Mitte (KEM), Essen</wicri:regionArea>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
</affiliation>
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<series><title level="j">BMC medical ethics</title>
<idno type="eISSN">1472-6939</idno>
<imprint><date when="2016" type="published">2016</date>
</imprint>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Access to Information</term>
<term>BRCA1 Protein (genetics)</term>
<term>Disclosure (ethics)</term>
<term>Female</term>
<term>Humans</term>
<term>Informed Consent</term>
<term>Mutation</term>
<term>Ovarian Neoplasms (diagnosis)</term>
<term>Ovarian Neoplasms (genetics)</term>
<term>Patient Preference</term>
<term>Prognosis</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Accès à l'information</term>
<term>Consentement libre et éclairé</term>
<term>Divulgation (éthique)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mutation</term>
<term>Pronostic</term>
<term>Protéine BRCA1 (génétique)</term>
<term>Préférence du patient</term>
<term>Tumeurs de l'ovaire (diagnostic)</term>
<term>Tumeurs de l'ovaire (génétique)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>BRCA1 Protein</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Ovarian Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Tumeurs de l'ovaire</term>
</keywords>
<keywords scheme="MESH" qualifier="ethics" xml:lang="en"><term>Disclosure</term>
</keywords>
<keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Ovarian Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Protéine BRCA1</term>
<term>Tumeurs de l'ovaire</term>
</keywords>
<keywords scheme="MESH" qualifier="éthique" xml:lang="fr"><term>Divulgation</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Access to Information</term>
<term>Female</term>
<term>Humans</term>
<term>Informed Consent</term>
<term>Mutation</term>
<term>Patient Preference</term>
<term>Prognosis</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Accès à l'information</term>
<term>Consentement libre et éclairé</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mutation</term>
<term>Pronostic</term>
<term>Préférence du patient</term>
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<front><div type="abstract" xml:lang="en">The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27769273</PMID>
<DateCreated><Year>2016</Year>
<Month>10</Month>
<Day>22</Day>
</DateCreated>
<DateCompleted><Year>2017</Year>
<Month>10</Month>
<Day>03</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>10</Month>
<Day>03</Day>
</DateRevised>
<Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1472-6939</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>17</Volume>
<Issue>1</Issue>
<PubDate><Year>2016</Year>
<Month>Oct</Month>
<Day>21</Day>
</PubDate>
</JournalIssue>
<Title>BMC medical ethics</Title>
<ISOAbbreviation>BMC Med Ethics</ISOAbbreviation>
</Journal>
<ArticleTitle>Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study.</ArticleTitle>
<Pagination><MedlinePgn>63</MedlinePgn>
</Pagination>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis. Mechanisms to communicate BRCA results were evaluated, because these findings may be beneficial to patients and their families.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Communicating individual BRCA results was not anticipated during clinical trial design. Consequently, options were not available for patients to indicate their preference for receiving their individual results when they signed pharmacogenetic informed consent. Differences in local requirements, clinical practice, and opinion regarding the ethical aspects of how to convey genetic results to patients are all potential barriers to returning individual BRCA results to patients. Communicating the aggregate BRCA result from this study provided clinical investigators with a mechanism to disseminate the overall study finding to patients while taking individual circumstances, local guidelines and clinical practice into account.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">This study illustrates the importance of increasing the clarity and scope of informed consent and the need for patient engagement to ensure clinical trial participants can indicate their preference regarding receipt of potentially important individual pharmacogenetic results.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">This study was registered in the NCT Clinical Trial Registry under NCT00866697 on March 19, 2009, following approval from participating ethics committees (Additional file 1).</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Pulford</LastName>
<ForeName>David J</ForeName>
<Initials>DJ</Initials>
<AffiliationInfo><Affiliation>GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK. david.x.pulford@gsk.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Harter</LastName>
<ForeName>Philipp</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>AGO Study group and Department of Gynecology & Gynecologic Oncology, Kliniken Essen Mitte (KEM), Essen, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Floquet</LastName>
<ForeName>Anne</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>GINECO and Medical Oncology, Institut Bergonié, Bordeaux, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Barrett</LastName>
<ForeName>Catherine</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>GSK Stockley Park West, 1-3 Iron Bridge Road, Uxbridge, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Suh</LastName>
<ForeName>Dong Hoon</ForeName>
<Initials>DH</Initials>
<AffiliationInfo><Affiliation>Department of Obstetrics & Gynecology, KGOG and Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Friedlander</LastName>
<ForeName>Michael</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>ANZGOG and The Prince of Wales Clinical School University of New South Wales, Randwick, NSW, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Arranz</LastName>
<ForeName>José Angel</ForeName>
<Initials>JA</Initials>
<AffiliationInfo><Affiliation>GEICO and Hospital General Universitario Gregorio Marañón, Madrid, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hasegawa</LastName>
<ForeName>Kosei</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>JGOG and Saitama Medical University International Medical Center, Hidaka, Japan.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Tada</LastName>
<ForeName>Hiroomi</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>GlaxoSmithKline Research and Development, Philadelphia, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Immuno-Oncology Development, Incyte Corporation, Wilmington, DE, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Vuylsteke</LastName>
<ForeName>Peter</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>BGOG and Medical Oncology, Université Catholique de Louvain, CHU UCL Namur, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mirza</LastName>
<ForeName>Mansoor R</ForeName>
<Initials>MR</Initials>
<AffiliationInfo><Affiliation>NSGO and Rigshospitalet, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Donadello</LastName>
<ForeName>Nicoletta</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>MaNGO and Ospedale Filippo del Ponte, Varese, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Scambia</LastName>
<ForeName>Giovanni</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Department of Woman Health, MITO and Catholic University of the Sacred Heart, Rome, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Johnson</LastName>
<ForeName>Toby</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cox</LastName>
<ForeName>Charles</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chan</LastName>
<ForeName>John K</ForeName>
<Initials>JK</Initials>
<AffiliationInfo><Affiliation>Palo Alto Medical Foundation, San Francisco, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Imhof</LastName>
<ForeName>Martin</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Karl Landsteiner Research Institute and Department of Obstetrics and Gynecology, General Public Teaching Hospital, Korneuburg, Vienna, Austria.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Herzog</LastName>
<ForeName>Thomas J</ForeName>
<Initials>TJ</Initials>
<AffiliationInfo><Affiliation>NYGOG and University of Cincinnati Cancer Institute, Cincinnati, OH, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Calvert</LastName>
<ForeName>Paula</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Cancer Trials Ireland, 60 Fitzwilliam Square N, Dublin 2, Ireland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wimberger</LastName>
<ForeName>Pauline</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>AGO Germany and Department of Gynecology and Obstetrics, TU Dresden, Carl-Gustav-Carus University, Dresden, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Berton-Rigaud</LastName>
<ForeName>Dominique</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>GINECO and ICO Centre René Gauducheau, Saint-Herblain, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lim</LastName>
<ForeName>Myong Cheol</ForeName>
<Initials>MC</Initials>
<AffiliationInfo><Affiliation>KGOG, Gynecologic Cancer Branch and Center for Uterine Cancer, National Cancer Center, Goyang, Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Elser</LastName>
<ForeName>Gabriele</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>AGO Study Group, Wiesbaden, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Xu</LastName>
<ForeName>Chun-Fang</ForeName>
<Initials>CF</Initials>
<AffiliationInfo><Affiliation>GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>du Bois</LastName>
<ForeName>Andreas</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>AGO Study group and Department of Gynecology & Gynecologic Oncology, Kliniken Essen Mitte (KEM), Essen, Germany.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT00866697</AccessionNumber>
</AccessionNumberList>
</DataBank>
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<PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>10</Month>
<Day>21</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>BMC Med Ethics</MedlineTA>
<NlmUniqueID>101088680</NlmUniqueID>
<ISSNLinking>1472-6939</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D019313">BRCA1 Protein</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="C492913">BRCA1 protein, human</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>E</CitationSubset>
<CitationSubset>IM</CitationSubset>
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