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Hormones

Conditioning therapy for bone marrow transplantation or pelvic irradiation. Fertility preservation is usually already proposed in this group of patients. No intervention.

Pathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML (Acute myeloide leukemia), osteosarcoma, Ewing sarcoma, neuroblastoma, non-Hodgkin lymphoma, Hodgkin lymphoma, soft tissue sarcoma, ALL (acute lymphoblastic hormone), Wilms tumour, retinoblastoma.

This is the study group we will compare with high risk and no risk patients. No intervention

Patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment.

No intervention

No intervention

Isabelle Demeestere, PhD

Julie Dechene

Morgan Collin

Nadine Francotte

Hanna Ryckaert

Joris Verlooy

Merry Vanpuyvelde

Bernard Wenderickx

Alina Ferster

Wiert Robberechts

Jutte Van der Werff

Els Vandecruys

Jemima Gaytant

Anne Uyttebroeck

Catherine Sondag

Caroline Piette

Sandy Vandermeersch

Hélène Sudour-Bonnange

Cécile Veron

Benedicte Bruno

Jean-Hugue Dalle

Jean- Hugue Dalle

Christine Decanter

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.

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 treated for cancer. The children enrolled are young patients between 3 and 14 year old who are newly diagnosed with cancer or benign diseases treated by chemotherapy and/or pelvic irradiation. They belong to one of these 3 groups (modified from Wallace et al, 2005):

* High risk
* Moderate/Low risk
* No risk (control group)

Primary endpoint:

Evaluate AMH as a potential biomarker of ovarian reserve in prepubertal/pubertal girl treated by chemotherapy (classified according to the AAD(Alkylating Agent Dose) score)

Secondary endpoints:

* Evaluate the association between the post-treatment ovarian reserve and the AMH pretreatment values in patients considered as moderate or low risk.
* Identify new patients group who may benefit from fertility preservation
* Compare the gonadotoxicity of chemotherapy regimen according to the pubertal status.
* Study the relation between the AMH levels and the pubertal age, menstruation cycle regularity, hormonal levels (FSH (follicle stimulating hormone), œstradiol, and testosterone) and bone age.

Different parameters will be assessed at inclusion, end of the treatment and during the follow-up (every year during the first 3 years and then every 2 years until the end of the study) Oncological outcome The patients will be followed up for progression and survival as per standard local practice.

Ovarian reserve and function:

Ovarian reserve will be evaluated based on hormonal dosages at different times of the study: FSH, AMH, estradiol, testosterone and LH (luteinizing hormone). Menstrual function will be evaluated by collecting information of the pubertal status (spontaneous or induced puberty) and menstrual cycle characteristics

Puberty evaluation:

All children will have an evaluation of the TANNER pubertal stage at 9 years of age (or later if \> 9 years old at the time of inclusion) and once a year until the end of puberty (when patients reach Tanner stage 5). An X-ray of the left hand and wrist will be carried out for bone age evaluation at 9-11 and 13 years old.

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

Blood test collection for serum storage. AMH values will be compared in the different groups and correlated with the cumulative doses of alkylating agents

Blood test collection for serum storage. FSH, E2 and AMH measurement and pubertal status. POF rate will be compared between groups

relation between the AMH levels, pubertal age, menstruation cycle regularity, hormonal levels (FSH, œstradiol, and testosterone at 16 year old) and bone age

Queen Fabiola Children's University Hospital

Erasme University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)	NCT02595255	Fertility Prese... Lymphoma Pediatrics Canc... Gonadotropin-re...	No intervention	3 Years - 14 Years	Erasme University Hospital
AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)	NCT02595255	Fertility Prese... Lymphoma Pediatrics Canc... Gonadotropin-re...	No intervention	3 Years - 14 Years	Erasme University Hospital

Spots Global Cancer Trial Database for pediatrics cancer