Childhood cancer, childhood hematological disease Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/01/2021: 1. Pre- and peripubertal boys (<18 years) who do not yet produce mature spermatozoa 2. Diagnosis of childhood cancer or childhood hematological disorders (<18 years) at the Universitair Ziekenhuis Brussel or the Hôpital Universitaire Des Enfants Reine Fabiola 3. High-risk gonadotoxic treatment (with an =80% risk of later fertility problems) 4. Did or did not undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy _____ Previous inclusion criteria: 1. Pre- and peripubertal boys (<18 years) who do not yet produce mature spermatozoa 2. Diagnosis of childhood cancer or childhood hematological disorders (<18 years) at the Universitair Ziekenhuis Brussel 3. High-risk gonadotoxic treatment (with an =80% risk of later fertility problems) 4. Did or did not undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy
Exclusion criteria
Exclusion criteria: 1. Diagnosis of testicular cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 21/01/2026: Impact of a testicular tissue biopsy procedure performed at a young age on pubertal and endocrine development using the following measurements at diagnosis and yearly until the age of 18 years (starting from the end of the gonadotoxic treatment): 1. A physical examination to measure the patient’s weight, height, body mass index, blood pressure, and testicular volume using a Prader orchidometer and to determine the patient’s Tanner stage (scoring of patient’s pubertal maturation) 2. A scrotum ultrasound to measure the patient’s testicular volume and to investigate potential abnormalities in the testicular parenchyma 3. A morning blood sample to evaluate the serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone (T), estradiol (E2), inhibin B (INHB), anti-Müllerian hormone (AMH), and insulin-like peptide 3 (INSL3), with mention of possible hormonal substitution treatment (start, duration, and dose prescribed) 4. An X-ray of the left hand and wrist to determine the patient’s bone age Previous primary outcome measure as of 11/01/2021: Impact of a testicular tissue biopsy procedure performed at a young age on pubertal and endocrine development using the following measurements at diagnosis and yearly until the age of 18 years (starting from the end of the gonadotoxic treatment): 1. A physical examination to measure the patient’s weight, height, body mass index, blood pressure, and testicular volume using a Prader orchidometer and to determine the patient’s Tanner stage (scoring of patient’s pubertal maturation) 2. A scrotum ultrasound to measure the patient’s testicular volume and to investigate potential abnormalities in the testicular parenchyma 3. A morning blood sample to evaluate the serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone (T), estradiol (E2), inhibin B (INHB), anti-Müllerian hormone (AMH), thyroid-stimulating hormone (TSH), fre | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/01/2021: 1. The patient's medical background: the diagnosis and the patient’s age at the time of diagnosis, the type of treatment received with mention of the cumulative dose (chemotherapy, radiotherapy, total body irradiation, bone marrow transplantation, type and frequency of surgery…) 2. Whether or not a testicular tissue biopsy procedure has been performed at a young age with mention of the testis portion biopsied (orchiectomy, hemi-orchiectomy, or smaller portion), the site of biopsy (left, right or bilateral), the patient’s age at the time of biopsy and the reason why the patient and his parents accepted or refused testicular tissue banking _____ Previous secondary outcome measures: 1. The patient's medical background: the diagnosis and the patient’s age at time of diagnosis, the type of treatment received with mention of the cumulative dose (chemotherapy, radiotherapy, total body irradiation, bone marrow transplantation, type and frequency of surgery, …) 2. Whether or not a testicular tissue biopsy procedure has been performed at a young age with mention of the testis portion biopsied (orchiectomy, hemi-orchiectomy or smaller portion), the site of biopsy (left, right or bilateral), the patient’s age at time of biopsy and the reason why the patient and his parents accepted or refused testicular tissue banking | — |
Countries
Belgium