Background: Neuroblastoma is the most frequent extracranial tumor in i
nfancy. The prognosis depends mainly on the age of the patient and the
extension of the tumor at diagnosis. In contrast to the poor prognosi
s of disseminated neuroblastoma, there is apparently the possibility o
f spontaneous regression in the first year of life. Up to now it is im
possible to differentiate these 2 subgroups in advance. Methods: The q
uestion, whether mass screening results in a substantial improvement o
f the prognosis of neuroblastoma, was first adressed in Japan more tha
n 20 years ago. Since then, more than 7 million infants at 6 months of
age have been screened in Japan. Another study was performed in Canad
a between 1989 and 1994. Pilot studies were initiated over the last ye
ars in the U.K., France, Austria, USA, Australia, Italy, Norway and Ge
rmany. The results of these studies show that neuroblastoma can be dia
gnosed early by detecting urinary catecholamine metabolites. There ist
no other acceptable alternative method for mass screening of neurobla
stoma today. The Japanese and Canadian data indicate the possibility o
f overdiagnosis of subclinical, possibly spontaneously regressing neur
oblastomas if the screening is performed before 6 months of age. For s
everal reasons (e.g. incomplete cancer registration), no statement abo
ut a decrease in mortality could be made. Conclusion: The newly initia
ted German study is an epidemiological approach to evaluate the presum
ed profit of neuroblastoma mass screening. The study population, infan
ts at 12 months of age, encompasses children in 6 states. A control po
pulation of similar size is formed by the rest of Germany. 1.25 millio
n screened infants will be compared to the same number of unscreened i
nfants. The German Children's Cancer Registry enables a mostly complet
e follow-up of all neuroblastoma patients in Germany, and therefore co
nclusive results on the impact of the procedure on mortality can be ex
pected. The results of this screening program will be crucial for the
implementation of neuroblastoma mass screening in the general preventi
onal program for children in Germany.