Etude : CHANCE /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : CHANCE

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 24/05/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Antimüllerian Hormone as a Predictor of Future Infertility Risk in Prepubertal/Pubertal Cancer Patients

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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.

Phase : NA

Stade : Localisé à Métastatique

NA
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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.

Critères de non-inclusion : - CNS 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 syndromes, uncontrolled severe diabetes, Cushing Syndrome, auto-immune diseases, cystic fibrosis, severe renal dysfunction)
- Genetic/congenital disorders inducing mental retardation
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02595255
Promoteur :
Erasme University Hospital
Type de sponsor : Institutionnel
Hôpital Erasme
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur SUDOUR-BONNANGE

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Ouverture de l'essai : OUVERT

MAJ : 24/05/2019