PReserving Fertility and Quality of Life IN Belgian Female Paediatric CancEr SurvivorS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 3
- 主要终点
- The index of fertility
研究概览
简要总结
Ovarian function impairment affects the quality of life of the survivors of paediatric cancer by impacting fertility, bone quality and mental and cognitive health. The objective of this project is to evaluate the impact of low-intermediate dose alkylating agents associated or not with ovarian cryopreservation technique on ovarian function in female survivors of paediatric cancer. We propose to identify new epigenetic markers in order to predict the risk of premature ovarian insufficiency. The project will be led by a national multi-disciplinary team (paediatric oncologists, gynaecologists, endocrinologists). Paediatric cancer clinical data (therapy, fertility preservation, ...) will be extracted from the Paediatrics Late Effects database and additional data will be collected during PRINCESS fertility evaluation. Through translational and multi-disciplinary approaches, results should improve quality of life and fertility preservation in female survivors of paediatric cancer by developing new personalised screening tools for premature ovarian insufficiency.
详细描述
A. Objectives:
In a cohort of female survivors of paediatric cancer aged of at least 18 years old at the time of evaluation, the main objectives of the project PRINCESS are:
- to evaluate the impact of low-intermediate dose alkylating agents on ovarian function and fertility;
- to assess the impact of ovarian tissue cryopreservation, used as fertility preservation technique, on further ovarian function and fertility;
- to identify new screening tools of premature ovarian insufficiency, using targeted and whole genome methylation techniques.
B. Project Design:
The complementarity of the promoters 'and co-applicants skills allows the building of a national translational team which relies on the pre-clinical, clinical and research expertise of paediatric oncologists (Drs Dedeken, De Ville de Goyet and Piette), endocrinologist (Dre Parent) and gynaecologists (Drs Demeestere, Dolmans, Henry and Jadoul). The promoter and co-promotor will directly supervise Dr Bianca David (PhD student) who will contribute to all aspects of the research. The PhD student will be hosted in the LBTD/GIGA-Cancer/Neurosciences and will benefit from its infrastructure, the help of technicians and the expertise of the AS Parent team for epigenetic studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Child and adolescent female patients included in the Paediatrics Late Effects Project:
- •diagnosed with cancer1 between 01/01/2004 and 31/12/2018
- •<17 years old at diagnosis
- •treated at CHU Liège site Citadelle or CHC, Cliniques Universitaires Saint-Luc and HUDERF
- •≥ 18 years-old at time of recruitment.
排除标准
- •Cancer diagnosis for controls
结局指标
主要结局
The index of fertility
时间窗: 2027
having children among survivors in compared with controls
The rate of menopause and POI
时间窗: 2027
Number of participants in POI
The rate of premature or delayed puberty
时间窗: 2027
Number of participants with premature/delayed puberty
The rate of use of medical help to become pregnant among survivors
时间窗: 2028
Number of participants using FIV
The rate of irregular menstruation, ovulatory disorders
时间窗: 2027
Number of participants with cycle disruptions
The rate of negative pregnancy outcome (miscarriage, medical abortion, stillbirth or birth
时间窗: 2028
Number of participants with pregnancy problems
次要结局
未报告次要终点
研究者
Bianca David
MD
Centre Hospitalier Universitaire de Liege
