Post-thrombotic Syndrome After Deep Venous Thrombosis (DVT) in Patients Treated According to the NOPHO ALL2008 Protocol
Sponsor
Aarhus University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04825548
Collaborator
(none)
30
1
33
0.9
Study Details
Study Description
Brief Summary
Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Today more than 90% of children and 75% of adults (18-45 years) survive ALL. The enzyme Asparaginase (Asp) is an indispensable part of the multiagent treatment of ALL.
Treatment related severe acute toxicities are common. Especially in teenagers and adults, thromboembolism is one of the most common acute toxicities and may result in post thrombotic syndrome (PTS) or pulmonary hypertension. The knowledge about these late effects is limited, including for ALL patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
30 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Post-thrombotic Syndrome After Deep Venous Thrombosis (DVT) in Patients Treated According to the NOPHO ALL2008 Protocol
Actual Study Start Date
:
Jul 1, 2020
Anticipated Primary Completion Date
:
Mar 31, 2023
Anticipated Study Completion Date
:
Apr 1, 2023
Outcome Measures
Primary Outcome Measures
- Number of patients with post thrombotic syndrome [01112020-01022023]
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Treated on the ALL2008 protocol for ALL. Had a DVT on treatment.
Exclusion Criteria:
- Death
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aarhus University Hospital | Aarhus N | Vælg En Region, Stat Eller Provins. | Denmark | 8200 |
Sponsors and Collaborators
- Aarhus University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Birgitte Klug Albertsen,
M.D., PhD, Associate Professor,
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT04825548
Other Study ID Numbers:
- PTS-NOPHOALL2008
First Posted:
Apr 1, 2021
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: