36 years childhood cancer registration in Germany. A network between clinics, clinical studies and the registry
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1 (GCCR) 36 years childhood cancer registration in Germany A network between clinics, clinical studies and the registry Peter Kaatsch Claudia Spix, Desiree Grabow 40 years Swiss Childhood Scientifc symposium, Bern, September 2016
2 Structure of presentation 1. The singularity of the German clinical studies in the paediatric oncology/haematology 2. How does the German Childhood work 3. Integrated information flow between hospitals, clinical studies and registry 4. The registry as backbone for epidemiological research 5. The long-term follow-up at the registry - with focus on second cancer
3 about 25 clinical trials / registries (Rossig C et al. Pediatr Blood Cancer 60, 2013)
4 (Rossig C et al. Pediatr Blood Cancer 60, 2013)
5 Participating rates in clinical trials by years of diagnosis : 69 % : 75 % : 89 % : 91 % : 93 % : 93 % : 96 %
6 How does the German Childhood work?
7 Location, financing, informed consent located at Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI) at the University Medical Centre Mainz long-term financing through Ministries of Health Federal ministry ministry in Rhineland-Palatinate ministries of 16 German states data protection no special legislation for the Childhood based on written consent of the concerned parents/patients
8 Notification form
9 Reporting hospitals
10 Integrated information flow between hospitals, clinical trial centres and registry From the beginning in 1980 onwards: each year: Data exchange between registry and all clinical trial centres
11 Integrated information flow between hospitals, clinical trial centres and registry (GCCR) Date of diagnosis Clinical treatment phase post clinical observation time general tumour specific general Notification form Tumour specific questionnaire Trial specific quest. on therapy Long-term follow-up * * hospital Clinical trial centre GCCR * alternatively
12 Integrated information flow between hospitals, clinical trial centres and Registry Synergy Effects Uniform reporting system for all oncological diseases Avoidance of repetitive documentation by treating doctors Further improvement of data quality (validation of notifications) High completeness of data
13 from our Annual Report 2015 based on 57,548 cancer cases ( )
14 from our Annual Report exemplary for leukaemias
15 from 1987 onwards: complete to a large extent
16 as backbone for epidemiological research
17 Epidemiologic research at the GCCR, e.g. regarding Aetiology Second cancer just 2 examples
18 Example 1 Case-control-study on aetiology of childhood cancer 2,358 cases (diseased in 1992 to 1994) and 2,588 controls very few selected results Our data suggest that atopic disease is associated with a reduced risk of childhood acute lymphoblastic leukaemia. A significant association was seen between childhood leukaemia and magnetic field exposure during the night (increased risk). (Schüz J et al. Int J Cancer 105, , 2003; Michaelis J et al. Epidemiology 9, 92-94, 1998)
19 Example 2 Case-control-study on second cancer 328 cases (cancer patients with a second tumor) and 639 controls cancer patients (without a second tumor) (Kaatsch et al. Cancer Causes Control 20, , 2009)
20 Long-term follow-up at the German Childhood
21 Long-term follow-up at the German Childhood Structural function contacting survivors in person regularly every 5 years starting at age 16 only a minimal data set (focus on relapse / second cancer) having available current addresses (inquiries at registration offices) more than 30,000 long-term survivors available for late-effects studies Systematic registration of second primaries after childhood cancer Several scientific projects on late effects based on the GCCR s long-term surveillance To minimize the burden for the survivors: Every first contact in these studies via GCCR
22 Number of patients in long-term surveillance from GCCR s Annual Report 2013/14 2 2
23 Long-term follow-up at the German Childhood Structural function contacting survivors regularly every 5 years starting at age 16 only a minimal data set having available current addresses of survivors more than 30,000 long-term survivors available for late-effects studies Systematic registration of second neoplasms after childhood cancer Several scientific projects on late effects based on the GCCR s long-term surveillance To minimize the burden for the survivors: Every first contact in these studies via GCCR
24 1105 cases with SP - reported to the GCCR - Combination of first and second primary First primary Carcinomas Leukaemias CNS *) tumours Second primary Lymphomas Soft tissue tumours Bone tumours Leukaemias CNS tumours *) Lymphomas Others Soft tissue sarcomas Tumours of sympath. nervous system Bone tumours ALL SMN % % % % % % Others % All primary malignancies % % % % % % % % *) CNS: central nervous system
25 Long-term follow-up at the German Childhood Structural function contacting survivors regularly every 5 years starting at age 16 only a minimal data set having available current addresses of survivors more than 30,000 long-term survivors available for late-effects studies Systematic registration of second primaries after childhood cancer Several scientific projects on late effects based on the GCCR s long-term surveillance To minimize the burden for the survivors: Every first contact in these studies via GCCR
26 Long-term follow-up at the German Childhood Structural function contacting survivors regularly every 5 years starting at age 16 only a minimal data set having available current addresses of survivors Systematic registration of second primaries after childhood cancer Several scientific projects on late effects based on the GCCR s long-term surveillance Some principles to minimize the burden for the survivors
27 Some principles how to get in touch with survivors Personal contact to survivors only via one and the same institution i.e. GCCR Avoidance of uncoordinated contact (from many different places) sending questionnaires all too frequent To inform survivors in time about the intention to contact them personally and routinely (e.g. at age 16 and via the parents) Participation is free of choice giving the survivors the chance to deny participation accept self-chosen lack of knowledge
28 Summary The German Childhood. is based on integrated information flow between hospitals, clinical trial centres and registry as backbone for epidemiological research performs an active long-term follow-up with focus an second cancer can help to minimize the burden for the survivors
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