Fertility and Ovarian Reserve in Female Childhood Cancer Survivors

NCT06626282 | Recruiting

• 3 other identifiers: OST 2022/21732023/388B7072023000101
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 3

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.

Conditions

Childhood Cancer Survivors; Fertility; Ovarian Reserve; CED; Ovarian Reserve Markers; Cryopreservation; Alkylating Agents; Female

Outcome Measures

Primary Outcomes (6)

• The index of fertility

  having children among survivors in compared with controls

  2027

• The rate of menopause and POI

  Number of participants in POI

  2027

• The rate of premature or delayed puberty

  Number of participants with premature/delayed puberty

  2027

• The rate of negative pregnancy outcome (miscarriage, medical abortion, stillbirth or birth

  Number of participants with pregnancy problems

  2028

• The rate of use of medical help to become pregnant among survivors

  Number of participants using FIV

  2028

• The rate of irregular menstruation, ovulatory disorders

  Number of participants with cycle disruptions

  2027

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: females without hormonal treatment in order to change gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Child and adolescent female patients included in the Paediatrics Late Effects Project. Controls will be age-, sex- and socio-economic-matched individuals starting with the siblings of the survivors. Belgian (http://statbel.fgov.be/en) public demographic, socioeconomic and birth registries will be used to exclude any bias in controls recruitment.

You may qualify if:

• 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
• alive
• ≥ 18 years-old at time of recruitment.

You may not qualify if:

• Cancer diagnosis for controls

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead
• La Fondation contre le cancer, Belgique: collaborator

Study Sites (3)

Hopital de la Citadelle

Liège, Wallonia, 4000, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, 1020, Belgium

NOT YET RECRUITING

HUDERF

Brussels, 1020, Belgium

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EDTA tubes

Central Study Contacts

Bianca David, MD

CONTACT

32 4 321 87 39; bianca.andreea.david@citadelle.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 3, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)