An observational study in Fertility Preservation, Lymphoma and Pediatrics Cancer, sponsored by Erasme University Hospital. Recruiting at 8 sites in 2 countries. Open to female participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Erasme University Hospital · Observational
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):
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:
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.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's planned enrollment of 275 is above the median of 167 across 393 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Erasme University Hospital is the lead sponsor of 181 studies on the registry; 35 are open to participants now.
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The population for this trial is patients between 3 and 14 year old newly diagnosed with cancer or benign diseases treated by chemotherapy and/or pelvic irradiation with high or moderate risk of inducing premature ovarian insufficiency. The "no risk" group includes patients with chronic benign diseases (as pneumology or gastroenterology diseases, congenital hypothyroidism, growth hormone deficiency or RCIU…) or malignancies who will not receive any chemotherapy or other gonadotoxic treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients from 3 to 14 year old included - Belong to one of these 3 groups (modified from Wallace et al, 2005):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conditioning therapy for bone marrow transplantation or pelvic irradiation. Fertility preservation is usually already proposed in this group of patients. No intervention.
Other: No intervention
Pathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML (Acute myeloid 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
Other: No intervention
Patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment. No intervention
Other: No intervention
No intervention
AMH marker
Blood test collection for serum storage. AMH values will be compared in the different groups and correlated with the cumulative doses of alkylating agents
Time frame: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
Premature ovarian failure (POF)
Blood test collection for serum storage. FSH, E2 and AMH measurement and pubertal status. POF rate will be compared between groups
Time frame: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
Ovarian reserve
relation between the AMH levels, pubertal age, menstruation cycle regularity, hormonal levels (FSH, œstradiol, and testosterone at 16 year old) and bone age
Time frame: screening, 1 year after screening, every year during the first 3 year of follow-up, every 2 years until 18 year old
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