Assessing adrenal function in children with leukemia after glucocorticoid treatment
A Swiss Prospective Multicenter Longitudinal Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children: An Explorative Study
University Children's Hospital Basel · NCT06861530
This study is trying to see how glucocorticoid treatment affects the adrenal function in children with leukemia to better understand and manage any potential hormone problems they might have after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University Children's Hospital Basel (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Aarau and 1 other locations) |
| Trial ID | NCT06861530 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the suppression of the hypothalamic-pituitary-adrenal (HPA) axis in children diagnosed with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who have received glucocorticoid therapy. The study will monitor the natural production of glucocorticoids in these patients after treatment, as glucocorticoids can lead to adrenal insufficiency, which poses additional health risks. The research will take place at the University Children's Hospital Basel and the Children's Hospital of Aarau, focusing on children treated with glucocorticoids for at least 21 days. The findings may help identify and manage adrenal insufficiency in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma who are receiving glucocorticoid therapy.
Not a fit: Patients who do not have a diagnosis of ALL or LBL or those who have contraindications to intravenous synthetic ACTH will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the detection and management of adrenal insufficiency in children undergoing treatment for leukemia.
How similar studies have performed: While there is existing literature on glucocorticoid effects, this specific assessment of HPA axis suppression in pediatric leukemia patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosed with ALL or LBL * treated for at least 21 sequential days with glucocorticoids between the 01.07.2024 and the 30.06.2027 at the Childrens University Hospital of Basel or at the Childrens Hospital of Aarau * lnformed consent can be obtained from the patient\'s legal representatives (and the patient if at least 14 years of age) within week 2 of treatment with glucocorticoids Exclusion Criteria: \- Contraindication to the administration of intravenous synthetical ACTH (Synacthen®): extremely rare cases of known or suspected hypersensitivity to Synacthen®.
Where this trial is running
Aarau and 1 other locations
- KSA — Aarau, Switzerland (RECRUITING)
- UKBB — Basel, Switzerland (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adrenal Insufficiency, Leukemia, Lymphoblastic, Acute, Pediatric, Lymphoma, Lymphoblastic, Adrenal insufficiency, leukemia, leukaemia, childhood, pediatric