Glucocorticoid induced HPA axis suppression in childhood acute lymphoblastic leukemia and lymphoma

Glucocorticoid induced HPA axis suppression in childhood acute lymphoblastic leukemia and lymphoma - CortisALL study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38085

Enrollment

Registered

2010-11-15

Start date

2010-12-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adrenal cortex insufficiency HPA axis suppression

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Newly diagnosed ALL, aged 1-19 years, treated according to the DCOG ALL-10 or its successor protocol. * Newly diagnosed Hodgkin lymphoma, aged 0-18 years, treated according to the EuroNet-Paediatric Hodgkin*s Lymphoma (PHL)-C1 protocol or the BEACOPP protocol or its successors. * Newly diagnosed non-Hodgkin lymphoma, aged 0-18 years, treated according the DCOG B-NHL/B-ALL 2008, the ALCL 99 protocol or the DCOG EURO-LB-02 protocol or its successors. * ALL or (non-)Hodgkin lymphoma, treated with high-dose glucocorticoids following HSCT. * Written informed consent of parents and in addition of children aged above 12 years.

Exclusion criteria

Exclusion criteria: * Glucocorticoid therapy for other reasons than treatment for ALL or (non-)Hodgkin lymphoma, since one year before diagnosis. * Personal or family history of HPA axis related diseases.

Design outcomes

Primary

Measure	Time frame
One week after the last (tapering) dose of the glucocorticoid courses, patients will be screened for HPA axis suppression by the low-dose ACTH stimulation test (LD ACTH test). In case of suppression, this test will be repeated until cortisol levels are normalized. Hereby, we will detect the number of patients with HPA axis suppression and the recovery time of the HPA axis function after high-dose glucocorticoid therapy. In addition, the predictive value of the low dose dexamethasone suppression test for developing HPA axis suppression will be determined. To determine the incidence of symptomatic (relative) hypocortisolism after administration of glucocorticoids, serum cortisol of all included patients presenting at our hospital with clinical symptoms of (relative) hypocortisolism during periods of stress, will be collected.	—

Measure

Time frame

One week after the last (tapering) dose of the glucocorticoid courses, patients will be screened for HPA axis suppression by the low-dose ACTH stimulation test (LD ACTH test). In case of suppression, this test will be repeated until cortisol levels are normalized. Hereby, we will detect the number of patients with HPA axis suppression and the recovery time of the HPA axis function after high-dose glucocorticoid therapy. In addition, the predictive value of the low dose dexamethasone suppression test for developing HPA axis suppression will be determined. To determine the incidence of symptomatic (relative) hypocortisolism after administration of glucocorticoids, serum cortisol of all included patients presenting at our hospital with clinical symptoms of (relative) hypocortisolism during periods of stress, will be collected.

—

Secondary

Measure	Time frame
Before starting the first glucocorticoid course, one week after the last (tapering) dose of this glucocorticoid course and after finishing treatment, blood will be drawn to measure the sensitivity of the glucocorticoid receptors on immune cells after high-dose glucocorticoid therapy.	—

Countries

Netherlands

Outcome results