GERMAN NEUROBLASTOMA MASS-SCREENING STUDY AT 12 MONTHS OF AGE - STATISTICAL ASPECTS AND PRELIMINARY-RESULTS

Background. The question oi whether screening for neuroblastoma (NB) r esults in a substantial improvement of the prognosis of the disease is still open. All data, including those of the European pilot studies, indicate the possibility of overdiagnosis in the case of possibly spon taneously regressing NBs if the screening is performed before 6 months of age. Based on two pilot studies (at 6 and 12 months), an epi demio logical approach to evaluate NB screening at 12 months of age was star ted in May 1995. Procedure. Extensive statistical considerations about the assessment of a the sample size and overdiagnosis have been made in preparing the study design of the controlled and population-based s creening validation study. Screening takes place in 6 of the 16 German states, with the remaining serving as controls. A minimum of 1,250,00 0 children will be tested during the study period and the same number will be followed without screening. The German Children's Cancer Regis try enables a nearly complete follow-up of all NB patients in Germany. By postponing the procedure to a later age, it should be possible to control the phenomenon of overdiagnosis at a reasonable level. Results . Until December 31, 1997, 644,396 children were examined and 67 cases of NB detected preclinically (detection rate: 10.4/100,000). Within t his cohort, three false negative cases were found. One child with stag e 2B neuroblastoma died of a surgical complication. The compliance rat e in this study is 65% and thus lower than expected. Preliminary resul ts on overdiagnosis will be available in late 1998. Med. Pediatr. Onco l. 31:435-441, 1998. (C) 1998 Wiley-Liss, Inc.