12 May 2014 PanCare Wroclaw 1
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2 PanCareLIFE Full Title: PanCare Studies in Fertility and Ototoxicity to improve Quality of Life after cancer during childhood or adolescence EU-funded project in Framework 7 : HEALTH : Investigator-driven supportive and palliative care clinical trials and observational studies 2
3 PanCareLIFE Management Coordinator: Peter Kaatsch, German Childhood Cancer Registry at UMC-Mainz TEAM: Desiree Grabow, Claudia Spix, Melanie Kaiser, Claudia Bremensdorfer, Harald Binder, Joshua Janis Research manager: Julie Byrne, Boyne Research Institute TEAM: Helen Campbell, Rebecca Lawler, Rosaire Kelly Administrative manager: Ciaran Clissmann, Pintail Ltd TEAM: Kylie O Brien, Bruff O Reilly 3
4 PanCareLIFE: List of participating organisations Participant no. Participant organisation name Participant name: Country 1 (Coordinator) Universitätsmedizin der Johannes Gutenberg- Universität Mainz Peter Kaatsch Germany 2 Boyne Research Institute Julie Byrne Ireland 3 Pintail Ltd Ciaran Clissmann Ireland 4 AcademischMedischCentrum Bij De Universiteit van Amsterdam (AMC) Leontien Kremer The Netherlands 5 UniversitätsKlinikum Erlangen Thorsten Langer Germany 6 Stichting VU-VUMC Eline van Dulmen-den Broeder The Netherlands 7 Erasmus UniversitairMedischCentrum Rotterdam (EMC) Marry van den Heuvel-Eibrink The Netherlands 8 Charite Universitätsmedizin Berlin Anja Borgmann Germany 9 Westfäelische Wilhelms-Universität Münster Gabriele Calaminus Germany 10 Universität Bern Claudia Kuehni Switzerland 11 Istituto Giannina Gaslini Riccardo Haupt Italy 12 Fakultni Nemocnice Brno Tomas Kepak Czech Republic 13 CHU St-Etienne Claire Berger France 14 Kraeftens Bekaempelse Jeanette Falck Winther Denmark 15 Fakultní nemocnice v Motole Jarmila Kruseová Czech Republic 4
5 PanCareLIFE Timetable for five years PHASE 1, Preparation Year 1, months 1-12, November 2013 October 2014 Prepare Study Protocols Obtain ethics approvals PHASE 2, Data collection Years 2 4, months 13-48, November 2014 October 2015 Data providers collect data, send to UMC-Mainz UMC-Mainz prepares analytic files, sends to WPL PHASE 3, Reporting Year 5, months 49 60, November 2016 October 2017 Analysis of data Reports & presentations Final report to EU 5
6 PanCareLIFE Timetable Phase 1 Progress Study Protocols being actively developed Variable lists being developed and harmonised Ethics approvals obtained for one institution Publication Committee good draft of Policy Brochures in draft stage 6
7 PanCareLIFE: List of work packages & work package leaders Work package no. Work package name Work package leader 1 Data centre & biostatistical support P. Kaatsch (UMC-Mainz, Germany) 2 Fertility preservation guidelines L. Kremer (AMC, Netherlands) 3 Female fertility impairment E. van Dulmen-den Broeder (VUMC, Netherlands) 4 Genetics of fertility impairment & hearing loss M. Van den Heuvel-Eibrink (EMC, Netherlands) 5 Ototoxicity T. Langer (UKER, Germany) 6 Health-related quality of life G. Calaminus(UKM, Germany) 7 Dissemination & exploitation C. Clissmann(Ireland) 8 Project management P. Kaatsch (UMC-Mainz, Germany) 7
8 PanCareLIFE: WP1 Data centre & biostatistical support Work package no. Work package name Work package leader 1 Data centre & biostatistical support P. Kaatsch (UMC-Mainz, Germany) WP1 a. Establish cohorts of survivors b. Extract and harmonise data c. Establish biostatistical support group 8
9 Work package no. PanCareLIFE Work Package 2: Fertility Guidelines and Intervention Work package name Work package leader 2 Fertility preservation guidelines L. Kremer (AMC, Netherlands) WP2a. Guidelines a. Fertility preservation in girls b. Fertility preservation in boys c. Recommendations for interventions WP2b. Intervention study Co-leaders: Anja Borgmann-Staudt, Julie Byrne 9
10 PanCareLIFE Work Package 2: Fertility Guidelines and Intervention Work package no. Work package name Fertility preservation guidelines Work package leader L. Kremer (AMC, Netherlands) WP2b. Intervention study DATA PROVIDERS Name Institution 1. Prof. Holger Cario Universitat Ulm, Germany 2. Prof. Arndt Borkhardt, Marina Kunstreich Heinrich-Heine Universitat, Germany 3. Prof. Herwig Lackner Medizinische Universitat Graz, Austria 4. Prof. Leo Kager St. Anna Kinderspital Wien, Austria 5. Prof. Maryna Krawczuk-Rybak Anna Panasiuk University Children s Hospital, Bialystok, Poland 6. Dr. Jarmila Kruseova 2 nd Medical Faculty and University Hospital Motol, Czech Republic 7. Dr. Tomas Kepak University Hospital Brno, Czech Republic 8. Prof. Uta Dirksen Universitatsklinikum Munster, Germany 10
11 PanCareLIFE Work Package 3: Female Fertility Impairment Work package no. Work package name Work package leader 3 Female fertility impairment E. van Dulmen-den Broeder (VUMC, Netherlands) a. Cohort study of female survivors to determine risk factors for infertility b. Nested case-control study to determine treatment-related risk factors for infertility With WP4, to investigate the ways in which genes modify the relationship between treatment and female infertility 11
12 Work package no. PanCareLIFE Work Package 3: Female Fertility Impairment Work package name Work package leader 3 Female fertility impairment E. van Dulmen-den Broeder (VUMC, Netherlands) Country Institute Study cohort Cohort size (n) DATA PROVIDERS Netherlands VU University Medical Center, Academic Medical Center Amsterdam, Erasmus Medical Center Rotterdam Questionnaires(n) DCOG LATER Study Netherlands Cancer Institute Amsterdam Hodgkin Lymphoma Study Germany WestfaelischeWilhelms-Universitaet Muenster VIVE study None Ewing 2008 Clinical Trials Charite - Universitaetsmedizin Berlin Berlin Hormone Analyses cohort 350? HaematologicStemcell Transplant cohort 344? Czech Republic FakultniNemocinice Brno Cohort malignant cancers >18 yrs FakultniNemocnice v Motole Cohort malignant cancers Italy IstitutoGianninaGaslini Neuroblastoma + CNS tumors cohort Switzerland Universitaet Bern Swiss Childhood Cancer Registry cohort None United Kingdom Great Ormond Street Children s Hospital London HSCT Norway Rikshospitalet-Radiumhospitalet Medical Center Hodgkins disease cohort Oslo France Centre HospitalierUniversitaire Saint Etienne Rhone Alpe cohort 1 (solid tumours and lymphoma diagnosed ) Rhone Alpe cohort 2 (solid tumours and lymphoma diagnosed ) Blood samples (n) 12 Total 13,223 6,287 2,014
13 PanCareLIFE Work Package 4: Genetics of Fertility Impairment & Hearing Loss Work package no. Work package name 4 Genetics of fertility impairment & hearing loss Work package leader M. Van den Heuvel-Eibrink (EMC, Netherlands) a. Confirm previously-identified markers for female gonadal toxicity b. Identify new susceptibility loci for female gonadal toxicity c. Identify genetic risk factors for platinum-related ototoxicity d. Identify new susceptibility loci for platinum-related ototoxicity With WP3, to investigate the ways in which genes modify the treatment-related risks of female infertility With WP5, investigate the ways in which genes modify the treatment-related risks for hearing loss 13
14 PanCareLIFE Work Package 4: Genetics of Fertility Impairment & Hearing Loss Work package no. Work package name 4 Genetics of fertility impairment & hearing loss Work package leader M. Van den Heuvel-Eibrink (EMC, Netherlands) DATA PROVIDERS, and numbers of subjects, total = 1450 Collaborating institute EMC (Netherlands) Responsible contact persons and team M.M. van den Heuvel-Eibrink, L. Stolk. A. G. Uitterlinden, J.S.E Laven, S. M. F. Pluijm, E. Clemens, J. Visser DCOG/VUMC E van Dulmen, M.M. van den Heuvel-Eibrink, L.C. Kremer 600 (Netherlands) NKI F. van Leeuwen 100 UNIBE (Swiss) C. Kuehni 150 GOSH (UK) A. Leiper 70 IGG (Italy) R. Haupt 50 FNM (Czech) J. Kruseova 50 UHB (Czech) T. Kepak 50 UKM U. Dirksen 100 CHU-SE (France) C. Berger Oslo May 2014 S. Fossa PanCare Wroclaw N 50
15 PanCareLIFE Work Package 5: Ototoxicity Work package no. Work package name Work package leader 5 Ototoxicity T. Langer (UKER, Germany) a. Identify non-genetic risk factors for ototoxicity in cancer survivors b. Identify different kinetic phenotypes of hearing deterioration by expert evaluation With WP4 investigate the ways in which genes modify the treatment-related risks for hearing loss 15
16 Work package no. PanCareLIFE Work Package 5: Ototoxicity Work package name Work package leader 5 Ototoxicity T. Langer (UKER, Germany) DATA PROVIDERS Participating site Responsible contact person Estimate of the number of cancer survivors who will meet the inclusion criteria UNIBE (Bern, Swiss) Claudia Kuehni UHB (Brno, Czech Republic) Tomas Kepak 265 IGG (Italy) Riccardo Haupt 60 KB (Denmark) Jeanette Falck Winter 120 FNM (Prague, Czech Republic) Jarmila Kruseova 100 AMC (Netherlands) Leontien Kremer EMC (Netherlands) Marry van den Heuvel-Eibrink 100 COSS/EURAMOS Stefan Bielack UKM (Münster, Germany) Antoinette am Zehnhoff-Dinnesen 150 TOTAL (600 minimum) 16
17 Work package no. PanCareLIFE: Work Package 6: Health-related Quality of Life Work package name Work package leader 6 Health-related quality of life G. Calaminus(UKM, Germany) a. Compare HRQoL in cancer survivors with population norms b. Determine predictors of HRQoL in survivors; c. Assess changes over time in HRQoL d. Develop models for HRQoL assessment e. With WP3, 4, & 5, investigate relationships between HRQoL and deficits in fertility and hearing 17
18 Work package no. PanCareLIFE Health-related Quality of Life Work package name Work package leader 6 Health-related quality of life G. Calaminus(UKM, Germany) DATA PROVIDERS 18
19 PanCareLIFE WP7: Dissemination & exploitations Work package no. Work package name Work package leader 7 Dissemination & exploitation C. Clissmann(Ireland) WP7: a. Communicate the project, mission, progress and results b. Maximise the research value for the partners and the wider research community 19
20 PanCareLIFE Timetable Phase 1 Progress DRAFT of PanCareLIFE banner 20
21 PanCareLIFE WP8: Project Management Work package no. Work package name Work package leader 18 Project Management P. Kaatsch (UMC-Mainz, Germany) WP8 a. Coordinate all activities b. Ensure that PanCareLIFE meets its contractual obligations c. Monitor progress 21
22 PanCareLIFE Kick-off Meeting Mainz, November
23 Holidays in Ireland 23
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