NCT02595255 AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)
| NCT ID | NCT02595255 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasme University Hospital |
| Condition | Fertility Preservation |
| Study Type | OBSERVATIONAL |
| Enrollment | 275 participants |
| Start Date | 2014-04 |
| Primary Completion | 2021-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 275 participants in total. It began in 2014-04 with a primary completion date of 2021-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 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
Contact & Investigator
Isabelle Demeestere, PhD
STUDY DIRECTOR
Erasme ULB- Belgium
Frequently Asked Questions
Who can join the NCT02595255 clinical trial?
This trial is open to female participants only, aged 3 Years or older, up to 14 Years, studying Fertility Preservation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02595255 currently recruiting?
Yes, NCT02595255 is actively recruiting participants. Contact the research team at idemeest@ulb.ac.be for enrollment information.
Where is the NCT02595255 trial being conducted?
This trial is being conducted at Montegnée, Belgium, Antwerp, Belgium, Brussels, Belgium, Brussels, Belgium and 6 additional locations.
Who is sponsoring the NCT02595255 clinical trial?
NCT02595255 is sponsored by Erasme University Hospital. The principal investigator is Isabelle Demeestere, PhD at Erasme ULB- Belgium. The trial plans to enroll 275 participants.