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A Swiss Prospective Multicenter Longitudinal Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children
Led by University Children's Hospital Basel · Updated on 2026-05-08
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Children's Hospital Basel
Lead Sponsor
G
Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Glucocorticoids are hormones that help control inflammation and regulate the immune system. In children with blood cancers like acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL), these hormones are given as medications to quickly reduce cancer cells. However, this treatment can suppress the body's natural glucocorticoid production, leading to a deficiency that increases infection risks and is hard to detect due to overlapping chemotherapy side effects. This study aims to understand how often and for how long this deficiency occurs in children with these cancers and to identify those at higher risk. The study observes children diagnosed with ALL or LBL who are treated with glucocorticoids for at least 21 consecutive days. Regular low-dose ACTH tests will be performed during and after treatment to assess the body's natural glucocorticoid production. These tests are done only when children already have venous access and are hospitalized for treatment, minimizing extra burden. The study follows participants from enrollment until three months after their last glucocorticoid dose. Participants will be monitored through these ACTH tests to detect adrenal insufficiency and its duration. The main outcome measured is the occurrence of adrenal insufficiency, with a secondary focus on how long it lasts. The study involves children up to 18 years old and takes place at two children's hospitals. The goal is to improve understanding and management of glucocorticoid deficiency during and after cancer treatment, with careful attention to the safety and comfort of the children involved.
CONDITIONS
Brief Title
A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL)
- Treated with glucocorticoids for at least 21 consecutive days between 01.07.2024 and 30.06.2027 at the Children's University Hospital of Basel or the Children's Hospital of Aarau
- Informed consent obtained from the patient's legal representatives (and from the patient if at least 14 years old) within week 2 of glucocorticoid treatment
You will not qualify if you...
- Known or suspected hypersensitivity to intravenous synthetic ACTH (Synacthen�), which is a contraindication for its administration
AI-Screening
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Your Study Journey
Duration - Up to 2 weeks after starting glucocorticoid treatment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and eligibility confirmation
Duration - From enrollment until 3 months after the last dose of glucocorticoid treatment
Participants who undergo glucocorticoid therapy are observed for adrenal insufficiency and hypothalamic-pituitary-adrenal axis suppression.
Visits scheduled as per routine clinical care; additional assessments may occur depending on cohort assignment
Trial Site Locations
Total: 2 locations
1
KSA
Aarau, Switzerland
Actively Recruiting
2
UKBB
Basel, Switzerland
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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