RecruitingNCT02595255

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

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


Sponsor

Erasme University Hospital

Enrollment

275 participants

Start Date

Apr 1, 2014

Study Type

OBSERVATIONAL

Conditions

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: FEMALEMin Age: 3 YearsMax Age: 14 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

Interventions

OTHERNo intervention

No intervention


Locations(10)

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

Montegnée, Liège, Belgium

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Hôpital Universitaire Reine Fabiola (HUDERF)

Brussels, Belgium

Universitair Ziekenhuis Brussels

Brussels, Belgium

UZ-Gent

Ghent, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Centre Hospitalier Régional (CHR)-Citadelle

Liège, Belgium

Centre Oscar Lambret

Lille, France

CHRU Lille-Hôpital Jeanne de Flandre

Lille, France

Hôpital Robert Debré

Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02595255


Related Trials