Therapy-related risk factors for second neoplasms after cancer in childhood - a population based nested case-control study (STATT - Second Tumour After Tumour Therapy, SCAR - Second Cancer After Radiotherapy)
- Conditions
- second neoplasm according to classification: ICCC-3 (International Classification of Childhood Cancer): ICCC-3 groups I-XI
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 6220
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, 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:
obefore the FPN recorded at the GCCR, at least one neoplasm occurred abroad
obefore the FPN recorded at the GCCR, at least one neoplasm occurred before 1980 in West Germany or before 1991 in East Germany
obefore the FPN recorded at the GCCR, at least one neoplasm occurred which was not an ICCC-3 neoplasm
othere was at least one neoplasm which was not an ICCC-3 neoplasm between the FPN and SPN or
obefore 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:
oIf the case recorded as SN is a transformation, a clonal diversity, a late event, or of unclear dignity.
oAn unverified and unverifiable subsequent case from an early period of the registry
oSecond neoplasm which had been collected by Dr. Gutjahr without verification or any additional information, only rough diagnosis etc. (details see Appendix 5)
oIf 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
owhich occurred abroad or
owhich 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:
obefore the FPN recorded at the GCCR, at least one neoplasm occurred abroad
obefore the FPN recorded at the GCCR, at least one neoplasm occurred before 1980 in West Germany or before 1991 in East Germany
obefore the FPN recorded at the GCCR, at least one neoplasm occurred which was not an ICCC-3 neoplasm or
obefore 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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