NCT06242353Not yet recruiting
Coagulopathy in Childhood Acute Lymphoblastic Leukaemia
Coagulopathy in Childhood Acute Lymphoblastic Leukaemia, Underlying Mechanisms and Ways to Optimise Treatment
Source: ClinicalTrials.gov · Last updated 5 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this study is to investigate the hemostatic balance in children with acute lymphoblastic leukaemia (ALL) treated according to the ALLTogether1 protocol with focus on the early treatment period including concomitant use of steroids and asparaginase. The investigators aim to determine if complement proteins or microparticles can be used as clinically relevant predictive or diagnostic biomarkers for thrombosis and if global hemostatic assays can predict bleeding or thrombosis. Characterization of proteins connected to hemostasis before and during ALL treatment may provide pathophysiological insights regarding ALL- and treatment related coagulopathy. The ultimate goal of the study is to minimize the morbidity and mortality related to thrombosis and bleeding complications in children with ALL. Several pediatric oncology centers in Sweden will be participating in this study, which will enroll approximately 100 pediatric patients.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 3 Oct 2023
- Start date
- 1 Mar 2024
- Primary completion date
- Nov 2026
- Lead sponsor
- Karolinska University Hospital
- NCT number
- NCT06242353
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Mar 2024 to the primary completion date, Nov 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other underlying diseases which according to examiner's clinical assessment may increase the risk of bleeding or thrombosis and which are expected to lead to adaption of the therapy protocol for ALL (e g APS, moderate/severe v Willebrand disease, haemophilia)
Other
- Patient not treated according to the ALLTogether1 protocol (including patients with BCR::ABL1, mixed phenotype acute leukaemia - MPAL)
Who the study is looking for
- Diagnosis of Acute Lymphoblastic Leukaemia (ALL) in Sweden
- Age 1-17.99 years at diagnosis
- Planned/Initiated treatment for ALL according to the ALLTogether1 protocol
- Signed informed consent from parents and patients (from 12 years - voluntary if \<15 years)
Age in the registry: 1 year to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.