NCT02595255

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 275 (estimated)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: Female
• Age: 3 Years – 14 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Fertility Preservation
• Lymphoma
• Pediatrics Cancer
• Gonadotropin-releasing Hormone Agonist

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2014-04-01
• Primary completion: 2021-12-01
• Completion: 2036-12-01
• First posted: 2015-11-03
• Last updated: 2020-05-04

Locations

10 sites across 2 countries: Belgium, France