- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03275311
2008년부터 전이성 유방암 치료의 진화 (ESME-MBC)
역학 전략 및 의료 경제(ESME) 연구 프로그램 / 학술적 실세계 데이터 플랫폼: 2008년부터 프랑스 종합 암 센터 전반에 걸친 전이성 유방암 치료의 진화
연구 개요
상태
정황
상세 설명
이 데이터베이스는 환자의 전자 의료 기록(EMR), 입원 환자 입원 기록 및 약국 기록의 데이터를 수집합니다.
환자 데이터베이스: 환자 관련 데이터는 환자 의료 기록 및 다분야 팀 회의 보고서와 같은 비정형 소스(전자 의료 기록)의 데이터를 통합합니다. 환자 인구 통계, 원시 종양, 재발, 병리학 보고서, 전이성 질환, 치료/설정 및 해당되는 경우 철회 이유, 임상 사건에 대한 정보를 제공할 수 있습니다.
치료 데이터베이스: 약국 기록 관련 데이터는 각 프랑스 종합 암 센터(FCCC) 내의 약국에서 처방 및 조제하는 약물, 특히 화학 요법 및 공동 처방과 관련된 모든 데이터를 포함하는 구조화된 데이터베이스입니다. 센터 외부에서 처방되거나 배송되는 제품에 대한 정보는 포함하지 않습니다. 각 센터의 약국 데이터베이스에서 전신 치료 패턴에 대한 정보(일자, 제형, 치료 프로토콜 등)를 얻을 수 있습니다.
입원 데이터베이스: 입원 관련 데이터는 FCCC의 모든 입원과 관련하여 보고된 모든 의료 데이터를 포함하는 체계적이고 체계적인 데이터베이스이며 프랑스 국민 건강 보험 기금(Assurance Maladie)에 청구하는 데 사용됩니다. 방사선 요법 및 수술을 포함하여 수행된 진단 및 치료 절차뿐만 아니라 환자 입원 및 퇴원 날짜에 대한 정보를 제공합니다.
최종 데이터베이스로 가져온 데이터는 데이터 관리 계획에 따라 가져오기 전에 제어, 기록 및 조화됩니다. 모든 코딩 절차는 데이터 관리자에 의해 미리 정의됩니다. 개별 데이터는 전송되지 않습니다. 모든 데이터는 공유 익명 형식을 사용하여 각 센터 내에서 중앙 집중화됩니다. 모든 데이터는 독점적으로 소급하여 얻습니다. 의료 제공자 또는 환자에게 연락하여 환자의 의료 기록에서 사용할 수 없는 데이터를 복구하려는 시도는 하지 않습니다.
ESME MBC 데이터 플랫폼은 FCCC에서 사용되는 다양한 소스의 기존 및 사용 가능한 데이터를 중앙 집중화하는 임상 및 치료 데이터베이스를 목표로 합니다.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Mathieu Robain, MD, PhD
- 이메일: m-robain@unicancer.fr
연구 연락처 백업
- 이름: Gaëtane Simon, Msc
- 이메일: g-simon@unicancer.fr
연구 장소
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Angers, 프랑스, 49933
- 모병
- Institut de Cancérologie de l'Ouest - Paul Papin
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연락하다:
- Geneviève PERROCHEAU
- 전화번호: +33 2 40 67 99 77
- 이메일: genevieve.perrocheau@ico.unicancer.fr
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연락하다:
- Loïc CAMPION
- 이메일: loic.campion@ico.unicancer.fr
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Bordeaux, 프랑스, 33076
- 모병
- Institut Bergonié
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연락하다:
- Anne JAFFRE
- 전화번호: +33 5 56 33 78 48
- 이메일: a.jaffre@bordeaux.unicancer.fr
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Caen, 프랑스, 14076
- 모병
- Centre François Baclesse
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연락하다:
- Anne-Valérie GUIZARD
- 전화번호: +33 2 31 45 52 45
- 이메일: av.guizard@baclesse.unicancer.fr
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Clermont-ferrand, 프랑스, 63011
- 모병
- Centre Jean Perrin
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연락하다:
- Marie-Ange MOURET-REYNIER
- 전화번호: +33 4 73 27 81 37
- 이메일: marie-ange.mouret-reynier@clermont.unicancer.fr
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Dijon, 프랑스, 21079
- 모병
- Centre Georges-Francois Leclerc
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연락하다:
- Sandrine DABAYUKO
- 전화번호: +33 45 34 80 67
- 이메일: SDabakuyo@cgfl.fr
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Lille, 프랑스, 59020
- 모병
- Centre Oscar Lambret
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연락하다:
- Marie-paule LEBITASY
- 전화번호: +33 3 20 29 55 60
- 이메일: m-lebitasy@o-lambret.fr
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Lyon, 프랑스, 69373
- 모병
- Centre Léon Bérard
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연락하다:
- Thomas Bachelot
- 전화번호: +33 4 78 78 26 54
- 이메일: thomas.bachelot@lyon.unicancer.fr
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Marseille, 프랑스, 13273
- 모병
- Institut Paoli-Calmettes
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연락하다:
- Lilian LABORDE
- 전화번호: +33 4 91 22 35 10
- 이메일: LABORDEL@ipc.unicancer.fr
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Montpellier, 프랑스, 34298
- 모병
- Institut régional du Cancer Montpellier / Val d'Aurelle
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연락하다:
- Stéphanie DELAINE
- 전화번호: +33 4 67 61 47 39
- 이메일: Stephanie.delaine@icm.unicancer.fr
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Nancy, 프랑스
- 모병
- Institut de Cancérologie de Lorraine
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연락하다:
- Carine LAURENT
- 전화번호: +33 3 83 59 83 32
- 이메일: c.laurent@nancy.unicancer.fr
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Nantes, 프랑스, 44805
- 모병
- Institut de cancérologie de l'Ouest - René Gauducheau
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연락하다:
- Geneviève PERROCHEAU
- 전화번호: +33 2 40 67 99 77
- 이메일: genevieve.perrocheau@ico.unicancer.fr
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연락하다:
- Loïc CAMPION
- 이메일: loic.campion@ico.unicancer.fr
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Nice, 프랑스, 06189
- 모병
- Centre Antoine Lacassagne
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연락하다:
- Emmanuel CHAMOREY
- 전화번호: +33 4 92 03 15 29
- 이메일: emmanuel.chamorey@nice.unicancer.fr
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Paris, 프랑스, 75005
- 모병
- Institut Curie
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연락하다:
- Etienne BRAIN
- 이메일: etienne.brain@curie.fr
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Reims, 프랑스, 51056
- 모병
- Institut Jean Godinot
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연락하다:
- Damien PARENT
- 전화번호: +33 3 26 50 42 76
- 이메일: damien.parent@reims.unicancer.fr
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Rennes, 프랑스, 35042
- 모병
- Centre Eugene Marquis
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연락하다:
- Mathias BRETON
- 전화번호: +33 2 99 25 32 67
- 이메일: m.breton@rennes.unicancer.fr
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Rouen, 프랑스, 76038
- 모병
- Centre Henri Becquerel
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연락하다:
- Agnès LOEB
- 전화번호: +33 2 32 08 22 80
- 이메일: agnes.loeb@chb.unicancer.fr
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Saint-Cloud, 프랑스, 92210
- 모병
- Institut Curie - Hopital Rene Huguenin
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연락하다:
- Etienne BRAIN
- 전화번호: +33 1 47 11 15 15
- 이메일: etienne.brain@curie.fr
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Strasbourg, 프랑스, 67065
- 모병
- Centre Paul Strauss
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연락하다:
- Michel VELTEN
- 전화번호: +33 3 88 25 24 53
- 이메일: mvelten@strasbourg.unicancer.fr
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Toulouse, 프랑스, 31059
- 모병
- Institut Claudius Regaud
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연락하다:
- Delphine BERCHERY
- 전화번호: 05 31 15 50 60
- 이메일: Berchery.Delphine@iuct-oncopole.fr
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Villejuif, 프랑스, 94805
- 모병
- Institut Gustave Roussy
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연락하다:
- Valérie DEJEAN
- 전화번호: +33 1 42 11 46 49
- 이메일: valerie.dejean@gustaveroussy.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
포함 기준 :
- 18세 환자
- 프랑스 종합 암 센터에서 화학 요법, 표적 요법, 면역 요법, 방사선 요법 및 호르몬 요법을 받는 환자.
제외기준 : 없음
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 회고전
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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치료 치료의 진화를 설명하십시오.
기간: 기준선
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환자 특성, 종양 특성 및 치료 패턴
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기준선
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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생존 기준에 대한 치료 전략의 영향을 설명합니다.
기간: 진단일 또는 최초 치료일로부터 어떤 원인으로든 사망한 날짜까지. 2023년까지 추적.
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전체 생존
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진단일 또는 최초 치료일로부터 어떤 원인으로든 사망한 날짜까지. 2023년까지 추적.
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생존 기준에 대한 치료 전략의 영향을 설명합니다.
기간: 진단 또는 첫 치료 날짜부터 처음으로 기록된 진행 날짜 또는 모든 원인으로 인한 사망 날짜까지. 2023년까지 추적.
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무진행 생존
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진단 또는 첫 치료 날짜부터 처음으로 기록된 진행 날짜 또는 모든 원인으로 인한 사망 날짜까지. 2023년까지 추적.
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 연구 책임자: Mathieu Robain, MD, PhD, UNICANCER
간행물 및 유용한 링크
일반 간행물
- Gobbini E, Ezzalfani M, Dieras V, Bachelot T, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Cleaud AL, Robain M, Courtinard C, Cailliot C, Perol D, Delaloge S. Time trends of overall survival among metastatic breast cancer patients in the real-life ESME cohort. Eur J Cancer. 2018 Jun;96:17-24. doi: 10.1016/j.ejca.2018.03.015. Epub 2018 Apr 13.
- Delaloge S, Perol D, Courtinard C, Brain E, Asselain B, Bachelot T, Debled M, Dieras V, Campone M, Levy C, Jacot W, Lorgis V, Veyret C, Dalenc F, Ferrero JM, Uwer L, Kerbrat P, Goncalves A, Mouret-Reynier MA, Petit T, Jouannaud C, Vanlemmens L, Chenuc G, Guesmia T, Robain M, Cailliot C. Paclitaxel plus bevacizumab or paclitaxel as first-line treatment for HER2-negative metastatic breast cancer in a multicenter national observational study. Ann Oncol. 2016 Sep;27(9):1725-32. doi: 10.1093/annonc/mdw260. Epub 2016 Jul 19.
- Jacquet E, Lardy-Cleaud A, Pistilli B, Franck S, Cottu P, Delaloge S, Debled M, Vanlemmens L, Leheurteur M, Guizard AV, Laborde L, Uwer L, Jacot W, Berchery D, Desmoulins I, Ferrero JM, Perrocheau G, Courtinard C, Brain E, Chabaud S, Robain M, Bachelot T. Endocrine therapy or chemotherapy as first-line therapy in hormone receptor-positive HER2-negative metastatic breast cancer patients. Eur J Cancer. 2018 May;95:93-101. doi: 10.1016/j.ejca.2018.03.013. Epub 2018 Apr 11.
- Cabel L, Carton M, Cheaib B, Pierga JY, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Desmoulins I, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Perrocheau G, Piot I, Perol D, Simon G, Lerebours F. Oral etoposide in heavily pre-treated metastatic breast cancer: results from the ESME cohort and comparison with other chemotherapy regimens. Breast Cancer Res Treat. 2019 Jan;173(2):397-406. doi: 10.1007/s10549-018-5017-2. Epub 2018 Oct 24.
- Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Mazouni C, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Goncalves A, Jankowski C, De La Motte Rouge T, Pouget N, de La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Robain M, Filleron T, Cailliot C, Dalenc F. Survival Impact of Locoregional Treatment of the Primary Tumor in De Novo Metastatic Breast Cancers in a Large Multicentric Cohort Study: A Propensity Score-Matched Analysis. Ann Surg Oncol. 2019 Feb;26(2):356-365. doi: 10.1245/s10434-018-6831-9. Epub 2018 Dec 11.
- Delaloge S, Perol D, Robain M, Cailliot C. Reply to 'The potential and perils of observational studies' by M. Buyse et al. Ann Oncol. 2017 Feb 1;28(2):436-437. doi: 10.1093/annonc/mdw572. No abstract available.
- Perol D, Robain M, Delaloge S, Cailliot C. Routinely collected data may usefully supplement randomised controlled data on treatment effects for mortality. BMJ. 2016 Dec 16;355:i6745. doi: 10.1136/bmj.i6745. No abstract available.
- Petitjean A, Smith-Palmer J, Valentine W, Tehard B, Roze S. Cost-effectiveness of bevacizumab plus paclitaxel versus paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer in specialist oncology centers in France. BMC Cancer. 2019 Feb 11;19(1):140. doi: 10.1186/s12885-019-5335-8.
- Perol D, Robain M, Arveux P, Mathoulin-Pelissier S, Chamorey E, Asselain B, Berchery D, Gourgou S, Breton M, Delaine-Clisant S, Mons M, Dieras V, Carton M, Guizard AV, Laborde L, Laurent C, Loeb A, Mouret-Reynier MA, Parent D, Perrocheau G, Campion L, Velten M, Cailliot C, Ezzalfani M, Simon G. The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the Epidemiological Strategy and Medical Economics (ESME). BMJ Open. 2019 Feb 21;9(2):e023568. doi: 10.1136/bmjopen-2018-023568.
- Jacot W, Heudel PE, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program. Int J Cancer. 2019 Dec 15;145(12):3359-3369. doi: 10.1002/ijc.32402. Epub 2019 Jun 20.
- Le Saux O, Lardy-Cleaud A, Frank S, Debled M, Cottu PH, Pistilli B, Vanlemmens L, Leheurteur M, Levy C, Laborde L, Uwer L, D'hondt V, Berchery D, Lorgis V, Ferrero JM, Perrocheau G, Courtinard C, Mouret-Reynier MA, Velten M, Breton M, Parent D, Chabaud S, Robain M, Bachelot T. Assessment of the efficacy of successive endocrine therapies in hormone receptor-positive and HER2-negative metastatic breast cancer: a real-life multicentre national study. Eur J Cancer. 2019 Sep;118:131-141. doi: 10.1016/j.ejca.2019.06.014. Epub 2019 Jul 19.
- Gougis P, Carton M, Tchokothe C, Campone M, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Bachelot T, Hennequin A, Perrin C, Goncalves A, Uwer L, Eymard JC, Petit T, Mouret-Reynier MA, Chamorey E, Simon G, Saghatchian M, Cailliot C, Le Tourneau C. CineBreast-factors influencing the time to first metastatic recurrence in breast cancer: Analysis of real-life data from the French ESME MBC database. Breast. 2020 Feb;49:17-24. doi: 10.1016/j.breast.2019.10.004. Epub 2019 Oct 19.
- Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Debled M, Mouret-Reynier MA, Goncalves A, Dalenc F, Delaloge S, Campone M, Augereau P, Ferrero JM, Levy C, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Chevrot M, Pasquier D, Bachelot T. Impact of breast cancer molecular subtypes on the incidence, kinetics and prognosis of central nervous system metastases in a large multicentre real-life cohort. Br J Cancer. 2019 Dec;121(12):991-1000. doi: 10.1038/s41416-019-0619-y. Epub 2019 Nov 13.
- Pasquier D, Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Petit A, Mouret-Reynier MA, Goncalves A, Dalenc F, Deluche E, Fresnel JS, Augereau P, Ferrero JM, Geffrelot J, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Mouttet-Audouard R, Bachelot T, Courtinard C. Treatment and outcomes in patients with central nervous system metastases from breast cancer in the real-life ESME MBC cohort. Eur J Cancer. 2020 Jan;125:22-30. doi: 10.1016/j.ejca.2019.11.001. Epub 2019 Dec 10.
- Deluche E, Antoine A, Bachelot T, Lardy-Cleaud A, Dieras V, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Courtinard C, Perol D, Robain M, Delaloge S. Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008-2016. Eur J Cancer. 2020 Apr;129:60-70. doi: 10.1016/j.ejca.2020.01.016. Epub 2020 Mar 2.
- Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Rivera S, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Goncalves A, Jankowski C, De La Motte Rouge T, Pouget N, De La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Courtinard C, Filleron T, Robain M, Dalenc F. Radiation therapy to the primary tumor for de novo metastatic breast cancer and overall survival in a retrospective multicenter cohort analysis. Radiother Oncol. 2020 Apr;145:109-116. doi: 10.1016/j.radonc.2019.12.019. Epub 2020 Jan 10.
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