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Clinical Trials in Belgium / NCT02595255
Recruiting Observational

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

NCT02595255 · tracked via the Priya Life Science Belgium tracker
Sponsor
Erasme University Hospital
Phase
Observational
Started
2014-04
Last updated
2026-08-12

Condition(s) studied

Fertility PreservationLymphomaPediatrics CancerGonadotropin-releasing Hormone Agonist

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention

Study summary

While most of the children spontaneously recover menstruation or experienced normal puberty after chemotherapy, their ovarian reserve may be impaired by treatment inducing future infertility. Fertility preservation is currently proposed for selected prepubertal patients with a high risk of premature ovarian failure after treatment (mostly conditioning regimen for bone marrow transplantation). For patients with low or moderate risks, counselling is very difficult and no fertility preservation procedure is usually proposed for these patients as no marker of the ovarian reserve has been validated in this young population to assess the individual risk.

The primary objective of the study is to prevent long-term treatment-related infertility by detecting the young patients who normally progressed to menarche but have a reduced ovarian reserve. These patients may benefit from particular follow-up and fertility preservation procedure.

Eligibility

Sex
FEMALE
Min age
3 Years
Max age
14 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • AMH marker — screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
    Blood test collection for serum storage. AMH values will be compared in the different groups and correlated with the cumulative doses of alkylating agents

Trial sites (8)

FacilityCityRegionStatus
Centre Hospitalier Chrétien (CHC)- Clinique de l'espérance Montegnée Liège Recruiting
Universitair Ziekenhuis Antwerpen Antwerp Belgium Recruiting
Hôpital Universitaire Reine Fabiola (HUDERF) Brussels Belgium Recruiting
Universitair Ziekenhuis Brussels Brussels Belgium 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

More Erasme University Hospital trials in Belgium

Characterisation of a Population of Adults Suffering From Cystic Fibrosis in a Belgian Reference Center Enrolling by invitation
Transfusion Surveillance in Anaesthesia Recruiting
CGM Boosted by Artificial Intelligence for Better Glycaemic Control in T2 Diabetes Active, not recruiting
Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure Recruiting
Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE) Recruiting

Other trials for the same condition

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma Active, not recruiting
Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas Active, not recruiting
PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study Recruiting
Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas Recruiting
A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02595255 on ClinicalTrials.gov ↗ ← All trials in Belgium