PanCareLife fertility study of female childhood cancer survivors v2
Research type
Research Study
Full title
Fertility impairment in a Pan-European cohort of female 5-year survivors of childhood cancer: PanCareLife study
IRAS ID
161089
Contact name
Victoria Grandage
Contact email
Sponsor organisation
PanCareLife
Clinicaltrials.gov Identifier
602030, PanCareLife (Health 2013 FP7) Grant agreement number; DP9-GOSH/UCLH- UK, Dataprovider reference number
Duration of Study in the UK
3 years, 6 months, 7 days
Research summary
Fertility Impairment in a pan-European cohort of female 5-year survivors of childhood cancer
The occurrence of fertility impairment following treatment for cancer during childhood has been known for at least 25 years. Overall, pregnancy rates have shown to be reduced by 20-35% in female survivors compared to siblings and the risk of early menopause is increased 13-fold. A significant number of studies relating to female fertility following childhood and adolescent cancer have failed to establish precise estimates of treatment-related risk. The contribution of genetic factors and effects of newer agents are also still lacking and many questions remain unanswered. The aim of the current cohort study is to generate evidence-based information concerning the risk factors and fertility status of adult female cancer survivors treated in childhood, adolescence and young adulthood,throughout Europe, on which evidence-based recommendations for counselling will be developed.
The study is set up as a retrospective cohort study (Part A) coordinated by the EU funded project PanCareLIfe and performed in collaboration with 11 European institutes. The cohort consists of over 13,000 5-year female survivors of childhood, adolescent and young adult cancer, currently >18 years of age. The main outcome of the study is fertility impairment. This outcome will be measured by means of self-reported data (questionnaires), completed for some survivors with clinical data that is to be collected during visits to outpatient clinics for late effects screening. The use of relatively new clinical markers of risk for fertility impairment, such as anti-Mullerian hormone (AMH), should provide more precise estimates of the risk of future (premature) loss of ovarian reserve.
From the nested case-control study (Part B) drawn from the cohort in Part A ,it will be investigated to what degree fertility impairment is related to the type of diagnosis and treatment, and age at time of treatment and treatment era.REC name
Wales REC 7
REC reference
15/WA/0152
Date of REC Opinion
30 Apr 2015
REC opinion
Favourable Opinion