Status:
RECRUITING
AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)
Lead Sponsor:
Erasme University Hospital
Collaborating Sponsors:
Queen Fabiola Children's University Hospital
Conditions:
Fertility Preservation
Lymphoma
Eligibility:
FEMALE
3-14 years
Brief 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. Fertilit...
Detailed Description
In this clinical trial, we will prospectively evaluate the AMH (Antimüllerian Hormone) level before and after treatment (up to 18 years old) in a large cohort of pre- and post-pubertal children treate...
Eligibility 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2036
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT02595255
Start Date
April 1 2014
End Date
December 1 2036
Last Update
May 4 2020
Active Locations (10)
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1
Centre Hospitalier Chrétien (CHC)- Clinique de l'espérance
Montegnée, Liège, Belgium, 4420
2
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium, 2650
3
Hôpital Universitaire Reine Fabiola (HUDERF)
Brussels, Belgium, 1020
4
Universitair Ziekenhuis Brussels
Brussels, Belgium, 1090