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The goal of this observational study is to learn about systemic and central nervous system (CNS) exposure to dexamethasone in childhood acute lymphoblastic leukaemia (ALL). The main questions it aims to answer are:
Participants will:
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Curve (AUC) of Dexamethasone | Blood samples | Repeated during induction, with AUC measurements on days 3, 4, and 15. Blood samples taken before dosing, and after 1, 2, 4, and 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mineral bone density by DXA-scan | DXA-scan | Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment. |
| Vertebral fracture assessment (VFA) by DXA-scan |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity questionnaire | Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment. | |
| Biomarkers of bone metabolism | Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment. |
Inclusion Criteria:
Exclusion Criteria:
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Children and adolescents diagnosed with ALL and treated according to the established and approved treatment protocol in Denmark
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Birgitte K Albertsen, Professor | Contact | +45 2022 4643 | biralber@rm.dk | |
| Karen S Jensen, phd | Contact | +45 61718432 | kascje@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Birgitte K Albertsen, Professor | Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital | Recruiting | Aalborg | Aalborg | 9000 | Denmark |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Blood samples
DXA-scan
| Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment. |
| Dexamethasone in cerebrospinal fluid | Comparing measurements of dexamethasone in blood and cerebrospinal fluid | When lumbar punctures are performed according to standard treatment during induction |
| Neurotoxicity | Questionnaire | On day 15 and day 29 of induction treatment |
| Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital | Recruiting | Aarhus N | Aarhus N | 8200 | Denmark |
|
| Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet | Recruiting | Copenhagen | København Ø | 2100 | Denmark |
|
| Department of Paediatrics and Adolescent Medicine, Odense University Hospital | Recruiting | Odense | Odense C | 5000 | Denmark |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |