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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2036
  • participants needed
    275
  • sponsor
    Erasme University Hospital
Updated on 25 January 2021
cancer
lymphoma
bone marrow transplant
hodgkin's disease
bone marrow procedure
chemotherapy regimen

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.

Description

In this clinical trial, we will prospectively evaluate the AMH (Antimllerian 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), stradiol, 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.

Details
Condition Lymphoma, Lymphoproliferative Disorder, Lymphoma, Non-Hodgkin's Lymphoma, Fertility Preservation, Pediatrics Cancer, Gonadotropin-releasing Hormone Agonist, Lymphoproliferative disorders, Gonadotropin-releasing Hormone Agonist, lymphomas, Gonadotropin-releasing Hormone Agonist
Treatment No intervention
Clinical Study IdentifierNCT02595255
SponsorErasme University Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 3 yrs and 14 yrs?
Are you female?
Do you have any of these conditions: Lymphoproliferative Disorder or Fertility Preservation or Lymphoma or Gonadotropin-releasing Hormone Agonist or Pediatrics Cancer or Lymphoproliferati...?
Do you have any of these conditions: Lymphoma or Non-Hodgkin's Lymphoma or Lymphoproliferative Disorder or Pediatrics Cancer or Gonadotropin-releasing Hormone Agonist or lymphomas or Lymp...?
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
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