Tumour of the central nervous system where 10Gy or more radiotherapy has been received to the hypothalamus or pituitary gland Cancer
Conditions
Interventions
Patients who have had radiotherapy for a brain tumour will be approached to take part in the study. When they have consented, they will undergo hormonal and metabolic testing every 4 months from the e
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
0 Years to 25 Years
Inclusion criteria
Inclusion criteria: 1. Aged 25 years or under at the end of cranial radiotherapy 2. Cranial irradiation for a primary central nervous system tumour 3. Trial recruitment within 8 months of the completion of cranial irradiation. If craniospinal radiotherapy is given, the cranial component must have completed within the previous 8 months 4. Hypothalamic or pituitary dose of = 10 Gy 5. Written informed consent from the patient and/or parent/legal guardian
Exclusion criteria
Exclusion criteria: 1. Serial dynamic hypothalamic assessments not possible due to social, geographic or psychological reasons 2. Patients with a hypothalamic-pituitary (HP) axis tumour having hypopituitarism including Growth Hormone deficiency at tumour diagnosis or after surgery 3. Patients with evidence of Growth Hormone deficiency 4. Females who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to develop biochemical Growth Hormone deficiency Time from end of radiotherapy treatment to develop biochemical Growth Hormone deficiency is defined as the difference between date of end of radiotherapy treatment and date of the first abnormal Growth Hormone test, as defined by each site’s local range. Biochemical Growth Hormone deficiency will be defined if the test results of the dynamic testing for Growth Hormone are abnormal. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to develop Growth Hormone deficiency is measured using local diagnosis based on dynamic testing for Growth Hormone, IGF-1, IGFBP3, height velocity, and weight velocity at baseline and follow-up timepoints 2. Time to develop Growth Hormone deficiency is measured using central diagnosis based on central review of dynamic testing for Growth Hormone, IGF-1, IGFBP3, height velocity, and weight velocity at baseline and follow-up timepoints 3. Proportion of patients with completed testing is measured using test completion records at each timepoint 4. Number of hypothalamic-pituitary axes with documented deficiency is measured using local reference ranges for ACTH/Cortisol, thyroid, gonadotropin, prolactin, and arginine vasopressin axes at each timepoint 5. Time to develop measurable hypothalamic-pituitary deficiency is measured using local reference ranges for each axis based on the date of first abnormal test result at baseline and follow-up timepoints 6. Number of hypothalamic-pituitary axes with documented deficiency is measured using local diagnosis based on site review of hypothalamic-pituitary tests at each timepoint 7. Time to develop measurable hypothalamic-pituitary deficiency is measured using local diagnosis based on site review of hypothalamic-pituitary tests at baseline and follow-up timepoints 8. Number of hypothalamic-pituitary axes with documented deficiency is measured using central diagnosis based on central review of hypothalamic-pituitary tests at each timepoint 9. Time to develop measurable hypothalamic-pituitary deficiency is measured using central diagnosis based on central review of hypothalamic-pituitary tests at baseline and follow-up timepoints 10. Number of metabolic tests with documented dysfunction is measured using local reference ranges for glucose, insulin, HbA1c, lipids, liver function, blood pressure, and BMI at each timepoint 11. Time to develop metabolic dysfunction is measured using local reference ranges for each metabolic tes | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactHelen Stone
Outcome results
None listed