Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06626282
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Fertility and Ovarian Reserve in Female Childhood Cancer Survivors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PReserving Fertility and Quality of Life IN Belgian Female Paediatric CancEr SurvivorS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRINCESS
Brief Summary:
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
Detailed Description:
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 LBTDGIGA-CancerNeurosciences and will benefit from its infrastructure the help of technicians and the expertise of the AS Parent team for epigenetic studies
Participants eligible to participate to the PRINCESS project n170 and controls n170 will be invited by a coordinating nurse to take part to PRINCESS fertility evaluation in the medically assisted reproduction centre of one of the three participating institutions During the first consultation the PRINCESS project will be explained to the participants who will sign an informed consent The expert with the help of the coordinating nurse will present the PRINCESS questionnaire including information about their fertility and parenthood situation to the participant who will then complete it in privacy A second consultation will take place after minimum 6 weeks without hormonal contraception and ideally between day 2-5 of the menstrual cycle During this consultation clinical biological and ultrasound evaluations will be performed see below data collection A third consultation will be organized to inform he participants of their results Participants will be offered a compensation for participating to the study
C Data collection
1 Data extracted from the Paediatrics Late Effects project at first paediatric cancer andor relapses andor progressions andor second cancers
Type of cancer
Dates of diagnosis and end of treatment
Treatment details type and doses of chemotherapy type and field of radiotherapy type of surgery stem cell transplantation
Fertility preservation measures
Relevant late effects endocrine gynaecology etc defined following the Common Terminology Criteria for Adverse Events version 403 2010-06-14
Vital status at last news
2 Data collected during PRINCESS fertility evaluation
Height weight body mass index
Puberty history date of menarche and menstrual cycles history
Pregnancies childbirth use of hormonal therapies including contraception
Menopause substitutive hormonal treatment
Measurement of LH FSH oestradiol progesterone prolactin TSH T4 AMH levels
Evaluation of the ovarian reserve by ultra-sound antral follicle count
Note one blood EDTA tube will be collected from each patient and stored in a bio-bank in CHU of Liege for later epigenetics analysis
Data collected by PRINCESS questionnaire Marital status Lifestyle tobaccocannabisalcohol consumption Level of education Occupation For children and adolescent female cancer survivors who ever tried to become pregnant use of medical help and type pregnancy course live birth with or without birth defect miscarriage medical abortion stillbirth
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 LBTDGIGA-CancerNeurosciences and will benefit from its infrastructure the help of technicians and the expertise of the AS Parent team for epigenetic studies
Participants eligible to participate to the PRINCESS project n170 and controls n170 will be invited by a coordinating nurse to take part to PRINCESS fertility evaluation in the medically assisted reproduction centre of one of the three participating institutions During the first consultation the PRINCESS project will be explained to the participants who will sign an informed consent The expert with the help of the coordinating nurse will present the PRINCESS questionnaire including information about their fertility and parenthood situation to the participant who will then complete it in privacy A second consultation will take place after minimum 6 weeks without hormonal contraception and ideally between day 2-5 of the menstrual cycle During this consultation clinical biological and ultrasound evaluations will be performed see below data collection A third consultation will be organized to inform he participants of their results Participants will be offered a compensation for participating to the study
C Data collection
1 Data extracted from the Paediatrics Late Effects project at first paediatric cancer andor relapses andor progressions andor second cancers
Type of cancer
Dates of diagnosis and end of treatment
Treatment details type and doses of chemotherapy type and field of radiotherapy type of surgery stem cell transplantation
Fertility preservation measures
Relevant late effects endocrine gynaecology etc defined following the Common Terminology Criteria for Adverse Events version 403 2010-06-14
Vital status at last news
2 Data collected during PRINCESS fertility evaluation
Height weight body mass index
Puberty history date of menarche and menstrual cycles history
Pregnancies childbirth use of hormonal therapies including contraception
Menopause substitutive hormonal treatment
Measurement of LH FSH oestradiol progesterone prolactin TSH T4 AMH levels
Evaluation of the ovarian reserve by ultra-sound antral follicle count
Note one blood EDTA tube will be collected from each patient and stored in a bio-bank in CHU of Liege for later epigenetics analysis
Data collected by PRINCESS questionnaire Marital status Lifestyle tobaccocannabisalcohol consumption Level of education Occupation For children and adolescent female cancer survivors who ever tried to become pregnant use of medical help and type pregnancy course live birth with or without birth defect miscarriage medical abortion stillbirth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None