second neoplasm according to classification: ICCC-3 (International Classification of Childhood Cancer): ICCC-3 groups I-XI
Conditions
Interventions
Group 1: Cases: patients who had a neoplasm during childhood (under 15 years old) and who had another neoplasm 6 months or more later
all patients were registered at the German Childhood Cancer Registry (GCCR) between 1980 and 2014
Status of registry as of March 2016
Group 2: patients who had a neoplasm during childhood (under 15 years old) and who did not have another neoplasm at least until a neoplasm occurred in the correspon
Status of registry as of March 2016
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Age
No minimum to 14 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria cohort: • GCCR registry dataset from 15 March 2016 • diagnosis of FPN and SPN included in ICCC-3 • FPN diagnosed between 1 January 1980 and 31 Dec 2014, age < 15 • recorded survival and follow-up of more than 6 months after FPN (365.25/2 days) • primary residency in Germany at time of diagnosis of FPN and SPN • due to latency period between FPN and SPN of at least 6 months (see below), technically the last date for FPN is 1 July 2014 Inclusion criteria cases: • SPN diagnosed between 1 January 1980 and 31 Dec 2014, any age • latency period (time between diagnosis of first and second neoplasm) at least 6 months (365.25/2 days) • due to latency period of at least 6 months, technically the last date for FPN is 1 July 2014 and first date for SPN is 2 July 1980
Exclusion criteria
Exclusion criteria: Exclusion criteria, study case: Study case: if the FN is in fact an SN or if the seemingly second neoplasm SPN is in fact the third neoplasm, which can occur in 5 situations: o before the FPN recorded at the GCCR, at least one neoplasm occurred abroad o before the FPN recorded at the GCCR, at least one neoplasm occurred before 1980 in West Germany or before 1991 in East Germany o before the FPN recorded at the GCCR, at least one neoplasm occurred which was not an ICCC-3 neoplasm o there was at least one neoplasm which was not an ICCC-3 neoplasm between the FPN and SPN or o before the FPN recorded at the GCCR, at least one neoplasm occurred which was not recorded as a case, but as an undated “pre-existing condition”, specifically pre-existing conditions with ICD10 D codes, ICD10 C codes or the codes E26.3 or L41.2. • Further decisions concerning SN based on further registry information about events and multiple neoplasms: o If the case recorded as SN is a transformation, a clonal diversity, a late event, or of unclear dignity. o An unverified and unverifiable subsequent case from an early period of the registry o Second neoplasm which had been collected by Dr. Gutjahr without verification or any additional information, only rough diagnosis etc. (details see Appendix 5) o If the diagnosis of SPN and FPN are identical at the ICCC3 extended level and (morphology is identical unless latency is more than five years). Exclusion criteria, study control: • if the potential control had a SPN before the SPN of the matching study case o which occurred abroad or o which was recorded, but not an ICCC-3 neoplasm (technically not an SPN) • if the FPN is in fact a SPN, which can have the following reasons: o before the FPN recorded at the GCCR, at least one neoplasm occurred abroad o before the FPN recorded at the GCCR, at least one neoplasm occurred before 1980 in West Germany or before 1991 in East Germany o before the FPN recorded at the GCCR, at least one neoplasm occurred which was not an ICCC-3 neoplasm or o before the FPN recorded at the GCCR, at least one neoplasm occurred which was not recorded as a case, but as an undated “pre-existing condition”, specifically pre-existing conditions with ICD10 D codes, ICD10 C codes or the codes E26.3 or L41.2. • case-by-case decision concerning a few problematic multiple tumors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| second neoplasm 6 months or later after cancer at age <15 years; second neoplasm must have been diagnosed by 31 Dec 2014 and registered and validated at the German Childhood Cancer Registry by March 2016 | — |
Secondary
| Measure | Time frame |
|---|---|
| specific second neoplasm 6 months or later after cancer at age <15 years; second neoplasm must have been diagnosed by 31 Dec 2014 and registered and validated at the German Childhood Cancer Registry by March 2016 | — |
Countries
Germany
Contacts
Public ContactClaudia Spix
Deutsches Kinderkrebsregister, Institut für Medizinische Biometrie, Epidemiologie und Informatik (IMBEI)Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Outcome results
None listed