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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36112
Enrollment
75
Registered
2011-05-10
Start date
2011-07-14
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Myelodysplastic syndrome -> bone marrow disorder

Interventions

Protocol pg. 14, 15 - MRI T2* liver: liver iron content - MRI T2* heart: myocardial iron content and ejection fraction - Echocardiography: evaluation of the left ventricular diastolic function

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Patients with previous intensive anti-leukemic therapy (intensive chemotherapy and/or stem cell transplantation). - Patients with secondary or therapy-related AML and MDS after chemotherapy for a malignancy or radiotherapy. - Patients with IPSS high risk MDS. - Patients with a contraindication for MRI: Metal body parts, internal defibrillator, pacemaker, neurostimulator, bladder stimulator, insulin pump, cochlear implant, claustrophobia or another reason that prohibits MRI evaluation.

Design outcomes

Primary

MeasureTime frame
Serum iron, serum ferritin, transferrin saturation level, hepcidin, GDF15 and sTfR. Iron overload as assessed by MRI T2* heart and liver and left ventricular function by echocardiography.

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)