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IJzerstapeling bij patiënten met MDS: De waarde van nieuwe ijzerparameters en MRI als voorspeller van ijzerstapeling.

Iron overload in MDS patients: The value of new iron parameters and MRI T2* of heart and liver as predictor of iron overload.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27359
Enrollment
75
Registered
2011-06-23
Start date
2011-07-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Myelodysplastic syndrome (MDS)

Interventions

Sponsors

University Medical Centre NIjmegen Departmetn of Hematology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with MDS according to WHO 2001-criteria (RA, RARS, RAEB-1, RAEB-2, RCMD, RCMD-RS, MDS with isolated del(5q), MDS-U); 2. Patient with IPSS low-risk, intermediate-1 or intermediate-2 risk; 3. Untreated patients or patients treated with blood transfusions, growth factors, iron chelation therapy, the immunomodulatory drug lenalidomide or the hypomethylating agents azacitidine or decitabine; 4. Informed consent and of legal age at the time of obtaining informed consent (≥18yrs).

Exclusion criteria

Exclusion criteria: 1. Patients with previous intensive anti-leukemic therapy (intensive chemotherapy and/or stem cell transplantation); 2. Patients with secondary or therapy-related AML and MDS after chemotherapy for a malignancy or radiotherapy; 3. Patients with IPSS high risk MDS; 4. Patients with a contraindication for MRI: Gadolinium allergy, impaired kidney function (MDRD <45 mL/min/1.73m2), metal parts, internal defibrillator, pacemaker, neurostimulator, bladder stimulator, insulin pump, cochlear implant, claustrophobia or another reason that prohibits MRI evaluation.

Design outcomes

Primary

MeasureTime frame
A relationship between T2*Liver and or T2*Heart levels and the number of blood transfusions.

Secondary

MeasureTime frame
Evidence for iron overload in transfusion-independent and transfusion-dependent MDS patients due to ineffective erythropoiesis.

Contacts

Public ContactM. MacKenzie

University Medical Centre Nijmegen Geert Grooteplein z8

M.MacKenzie@HEMAT.umcn.nl+31 (0)24 3614762

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)