DRKS00017847招募中不适用
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) - STATT-SCAR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- one 至 14 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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