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临床试验/NCT06626282
NCT06626282招募中不适用

PReserving Fertility and Quality of Life IN Belgian Female Paediatric CancEr SurvivorS

Centre Hospitalier Universitaire de Liege3 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2024年10月9日最近更新:
适应症

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:

  1. to evaluate the impact of low-intermediate dose alkylating agents on ovarian function and fertility;
  2. to assess the impact of ovarian tissue cryopreservation, used as fertility preservation technique, on further ovarian function and fertility;
  3. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bianca David

MD

Centre Hospitalier Universitaire de Liege

研究点 (3)

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