Reproductive function in TYA cancer survivors. (The PROTECT study)
Research type
Research Study
Full title
Reproductive function in teenage and young adult Cancer patients in the UK.
IRAS ID
285290
Contact name
Richard A Anderson
Contact email
Sponsor organisation
Univeristy of Edinburgh
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This study will undertake analysis of the effects of cancer treatments on reproductive function in teenagers and young adults (TYA) to address our hypothesis that cancer diagnosis, cancer treatment and age at treatment effect fertility-related biomarkers and hence long-term fertility/reproductive health in survivors. This is a multi-centre clinical prospective observational cohort study open to clinical centres directly involved in the care of TYA (aged 13-25) with cancer.
Previous studies are retrospective thus assessing historical treatments, and mostly rely on questionnaire-based self-reported outcomes, introducing the opportunity for bias and inaccuracy. Additionally, there is a need for data specific to this post-pubertal age group, distinct from children.
For individual patients, a personal assessment of post-recovery reproductive function following new and emerging treatment regimens is essential, and individualised prediction of that risk is necessary for accurate information provision at the time of diagnosis to allow informed decision-making regarding the need for fertility preservation interventions. Currently, understanding of reproductive physiology allows biomarkers to be used with confidence to reflect and predict gonadal function and fertility in oncologic practice, with the potential for a more detailed detection of partial loss of gonadal function, but this requires validation in larger prospective patient groups.
This prospective study will combine biomarker and clinical analysis pre-treatment as well as post-treatment, with the generation of accurate risk assessment for rarer diagnoses/treatments as well as the more common ones, and of new treatments as they emerge: at present there are almost no data on the potential reproductive effects of targeted therapies. This study will recruit TYA patients from UK cancer centres, providing detailed individual assessment and long-term follow-up to address the need for prospective data on well-characterised patients, encompassing the rapid changes in oncological practice.REC name
South West - Frenchay Research Ethics Committee
REC reference
21/SW/0053
Date of REC Opinion
20 Jul 2021
REC opinion
Further Information Favourable Opinion