Using AMH levels to predict infertility risk in children with cancer
Antimüllerian Hormone as a Predictor of Future Infertility Risk in Prepubertal/Pubertal Cancer Patients
Erasme University Hospital · NCT02595255
This study is trying to see if measuring a hormone called AMH can help predict the risk of infertility in children with cancer who are starting treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 275 (estimated) |
| Ages | 3 Years to 14 Years |
| Sex | Female |
| Sponsor | Erasme University Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Montegnée, Liège and 9 other locations) |
| Trial ID | NCT02595255 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the levels of Antimüllerian Hormone (AMH) in children aged 3 to 14 who are newly diagnosed with cancer and treated with chemotherapy or pelvic irradiation. The study categorizes participants into high, moderate/low, and no risk groups based on their treatment regimens and aims to identify those at risk of reduced ovarian reserve. By monitoring AMH levels before and after treatment, the study seeks to provide insights into fertility preservation options for young patients who may face infertility due to cancer treatments. Follow-up assessments will occur annually for the first three years and then every two years until the study concludes.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 14 diagnosed with cancer or benign diseases requiring chemotherapy or pelvic irradiation.
Not a fit: Patients with central nervous system irradiation, previous ovarian disease, or those with a familial history of premature ovarian failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify young cancer patients at risk of infertility, allowing for timely fertility preservation interventions.
How similar studies have performed: While the approach of using AMH as a biomarker in this specific pediatric population is novel, similar studies in adult populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients from 3 to 14 year old included - Belong to one of these 3 groups (modified from Wallace et al, 2005): * High risk : Conditioning therapy for bone marrow transplantation or pelvic irradiation * Moderate/Low risk : Pathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML, osteosarcoma, Ewing sarcoma, neuroblastoma, non-Hodgkin lymphoma, Hodgkin lymphoma, soft tissue sarcoma, ALL, Wilms tumour, retinoblastoma. * No risk (control group) : patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment. Exclusion Criteria: * CNS (central nervous system) irradiation, cerebral tumour * Current or previous ovarian disease/surgery * Familial history of premature ovarian failure (no iatrogenic or surgical origins) * Previous known severe chronic disease potentially affecting normal growth or puberty (diseases inducing malnutrition, anorexia, genetic/congenital disorders as Turner, Kallman, BPES(Blepharophimosis, ptosis, and epicanthus inversus syndrome) syndromes, uncontrolled severe diabetes, Cushing Syndrome, auto-immune diseases, cystic fibrosis, severe renal dysfunction) * Genetic/congenital disorders inducing mental retardation
Where this trial is running
Montegnée, Liège and 9 other locations
- Centre Hospitalier Chrétien (CHC)- Clinique de l'espérance — Montegnée, Liège, Belgium (RECRUITING)
- Universitair Ziekenhuis Antwerpen — Antwerp, Belgium (RECRUITING)
- Hôpital Universitaire Reine Fabiola (HUDERF) — Brussels, Belgium (RECRUITING)
- Universitair Ziekenhuis Brussels — Brussels, Belgium (RECRUITING)
- UZ-Gent — Ghent, Belgium (NOT_YET_RECRUITING)
- Universitair Ziekenhuis Leuven — Leuven, Belgium (RECRUITING)
- Centre Hospitalier Régional (CHR)-Citadelle — Liège, Belgium (RECRUITING)
- Centre Oscar Lambret — Lille, France (RECRUITING)
- CHRU Lille-Hôpital Jeanne de Flandre — Lille, France (RECRUITING)
- Hôpital Robert Debré — Paris, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Alina Ferster — Queen Fabiola children's university hospital- Belgium
- Study coordinator: Isabelle Demeestere, PhD
- Email: idemeest@ulb.ac.be
- Phone: +32 2 555 65 92
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fertility Preservation, Lymphoma, Pediatrics Cancer, Gonadotropin-releasing Hormone Agonist, chemotherapy/GnRH analogues/lymphoma/children/fertility