Actively Recruiting

Age: 3Years - 14Years
FEMALE
ID02595255

Antimüllerian Hormone as a Predictor of Future Infertility Risk in Prepubertal/Pubertal Cancer Patients

Led by Erasme University Hospital · Updated on 2020-05-04

275

Participants Needed

10

Research Sites

782 weeks

Total Duration

On this page

Sponsors

E

Erasme University Hospital

Lead Sponsor

Q

Queen Fabiola Children's University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how Antimüllerian Hormone (AMH) levels can predict the risk of future infertility in girls aged 3 to 14 who are undergoing cancer treatment or treatment for benign diseases. The goal is to identify young patients who may have a reduced ovarian reserve after treatment and could benefit from special follow-up or fertility preservation. The study includes children at high, moderate/low, or no risk of ovarian damage from chemotherapy or pelvic irradiation. The study observes AMH and other hormone levels before and after treatment, with no interventions applied. Participants are grouped by their risk level: high risk patients receiving conditioning therapy or pelvic irradiation; moderate/low risk patients treated with chemotherapy regimens for various cancers; and a control group with no risk, consisting of patients with benign diseases or cancers not requiring gonadotoxic treatment. Assessments occur at diagnosis, treatment end, and during follow-up visits scheduled yearly for three years, then every two years until age 18. Participants will have their ovarian reserve evaluated through hormone tests including AMH, FSH, estradiol, testosterone, and LH, alongside menstrual cycle tracking and pubertal development assessed annually using Tanner staging and bone age X-rays. The primary outcome is the AMH marker measured regularly up to 18 years old. Secondary outcomes include premature ovarian failure and ovarian reserve changes. The study also monitors oncological outcomes as per standard care, with a total follow-up duration extending to 18 years old.

CONDITIONS

Brief Title

AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)

Who Can Participate

Age: 3Years - 14Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 3 to 14 years old
  • Patients belonging to one of three risk groups: high risk (conditioning therapy for bone marrow transplantation or pelvic irradiation), moderate/low risk (chemotherapy for specified cancers), or no risk (no chemotherapy or gonadotoxic treatment)
  • Diagnosed with cancer or benign diseases requiring chemotherapy and/or pelvic irradiation
  • Newly diagnosed patients at the time of enrollment
Not Eligible

You will not qualify if you...

  • History of central nervous system irradiation or cerebral tumor
  • Current or previous ovarian disease or ovarian surgery
  • Family history of premature ovarian failure not caused by treatment or surgery
  • Severe chronic diseases affecting growth or puberty (including malnutrition, anorexia, genetic/congenital disorders like Turner or Kallman syndromes, uncontrolled diabetes, Cushing Syndrome, autoimmune diseases, cystic fibrosis, severe renal dysfunction)
  • Genetic or congenital disorders causing mental retardation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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) at inclusion

Diagnostic Evaluation

Duration - At inclusion

Participants undergo baseline evaluations including hormonal dosages and pubertal status assessment to determine ovarian reserve and puberty stage.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Up to 15 years until participants reach 18 years old

Participants are monitored over time with repeated hormonal assessments, puberty evaluations, and bone age X-rays to track ovarian reserve and pubertal development.

Annual visits for the first 3 years, then every 2 years until age 18

Trial Site Locations

Total: 10 locations

1

Centre Hospitalier Chrétien (CHC)- Clinique de l'espérance

Montegnée, Liège, Belgium, 4420

Actively Recruiting

2

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium, 2650

Actively Recruiting

3

Hôpital Universitaire Reine Fabiola (HUDERF)

Brussels, Belgium, 1020

Actively Recruiting

4

Universitair Ziekenhuis Brussels

Brussels, Belgium, 1090

Actively Recruiting

5

UZ-Gent

Ghent, Belgium

Not Yet Recruiting

6

Universitair Ziekenhuis Leuven

Leuven, Belgium, 3000

Actively Recruiting

7

Centre Hospitalier Régional (CHR)-Citadelle

Liège, Belgium, 4000

Actively Recruiting

8

Centre Oscar Lambret

Lille, France, 59000

Actively Recruiting

9

CHRU Lille-Hôpital Jeanne de Flandre

Lille, France, 59037

Actively Recruiting

10

Hôpital Robert Debré

Paris, France

Not Yet Recruiting

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Research Team

I

Isabelle Demeestere, PhD

J

Julie Dechene

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Anti-Müllerian hormone is a marker of gonadotoxicity in pre- and postpubertal girls treated for cancer: a prospective study.

Mark F H Brougham, Patricia M Crofton, Emma J Johnson...

https://pubmed.ncbi.nlm.nih.gov/22472563

Fertility preservation for girls and young women with cancer: population-based validation of criteria for ovarian tissue cryopreservation.

W Hamish B Wallace, Alice Grove Smith, Thomas W Kelsey...

https://pubmed.ncbi.nlm.nih.gov/25130994