Actively Recruiting

Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID06626282

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

Led by Centre Hospitalier Universitaire de Liege · Updated on 2024-11-01

340

Participants Needed

3

Research Sites

104 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire de Liege

Lead Sponsor

L

La Fondation contre le cancer, Belgique

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on female survivors of pediatric cancer who are at least 18 years old. It aims to evaluate how low to intermediate doses of alkylating agents, with or without ovarian tissue freezing (cryopreservation), affect ovarian function and fertility. The study also seeks to discover new epigenetic markers to predict the risk of premature ovarian insufficiency. A national team of pediatric oncologists, gynecologists, and endocrinologists is leading this project to improve fertility preservation and quality of life for these survivors. Participants include female childhood cancer survivors and controls who will undergo evaluations at medically assisted reproduction centers. The project involves several consultations: an initial visit for informed consent and questionnaire completion about fertility and parenthood, a second visit for clinical, biological, and ultrasound assessments after a hormone-free period, and a third visit to discuss results. Blood samples will be collected for epigenetic studies, and clinical data from the Paediatrics Late Effects database will complement the research. Throughout the study, participants will provide detailed medical and lifestyle information, including cancer treatment history, fertility preservation, menstrual cycles, hormone levels, and ovarian reserve measured by ultrasound. Researchers will monitor fertility outcomes such as menopause rates, premature ovarian insufficiency, pregnancy outcomes, and use of medical help to conceive. The study also tracks irregular menstruation and ovulatory disorders. Participants may receive compensation, and the study is planned to continue until 2028.

CONDITIONS

Brief Title

Fertility and Ovarian Reserve in Female Childhood Cancer Survivors

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients included in the Paediatrics Late Effects Project
  • Diagnosed with cancer between 01/01/2004 and 31/12/2018
  • Younger than 17 years at cancer diagnosis
  • Treated at CHU Li�e8ge site Citadelle or CHC, Cliniques Universitaires Saint-Luc and HUDERF
  • Alive at time of recruitment
  • At least 18 years old at recruitment
Not Eligible

You will not qualify if you...

  • Cancer diagnosis for control participants

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for initial consultation and informed consent

Diagnostic Evaluation

Duration - At least 6 weeks between evaluations

Participants complete a fertility questionnaire and undergo clinical, biological, and ultrasound evaluations to assess ovarian function and fertility.

2 visits (in-person): one to complete questionnaire, second for clinical and ultrasound assessments

Results Consultation

Duration - Occurs after diagnostic evaluations

Participants are informed of their fertility evaluation results during a follow-up consultation.

1 visit (in-person) to discuss results

Trial Site Locations

Total: 3 locations

1

Hopital de la Citadelle

Liège, Wallonia, Belgium, 4000

Actively Recruiting

2

Cliniques Universitaires Saint-Luc

Brussels, Belgium, 1020

Not Yet Recruiting

3

HUDERF

Brussels, Belgium, 1020

Not Yet Recruiting

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Research Team

B

Bianca David, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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