Functional Iron Deficiency
Conditions
Brief summary
Prospective single-center observational study assessing prevalence of FID (Laboratory work-up) and Quality of Life (Questionnaire) in adult patients with oncological and with haematological malignancies within four weeks prior to disease-directed therapy.
Detailed description
Patients included into the study will have a laboratory work-up assessing the occurence of functional iron deficiency using laboratory parameters (full blood count, reticulocytes, transferrin saturation, serum-ferritin, CRP, ALAT) and have to fill in once the FACT-An questionnaire generating data on Quality of Life at time of study entry.
Interventions
None listed
Sponsors
Luzerner Kantonsspital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Patients with oncological (solid tumors) and with haematological malignancies (non-solid tumors, including Plasma cell myeloma, lymphoma, myeloproliferative neoplasias \[MPN\], myelodysplastic syndromes \[MDS\] and chronic leukemias) * Within four weeks prior to disease-directed systemic therapy * Participation in other trials is possible
Exclusion criteria
* Known iron deficiency with or without iron substitution p.o. or i.v. within last 8 weeks prior to inclusion into this trial * Therapy with RBC-transfusions within last 8 weeks prior to inclusion into this trial * Therapy with ESA within last 8 weeks prior to inclusion into this trial * Malignancies with acute need for therapeutic intervention (e.g. acute leukemias, superior vena cava obstruction, etc.) * Pregnancy * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the trial * Inability to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is the determination of the prevalence of FID in patients with oncological and with haematological malignancies. | through study completion, an average of 1 year | Prevalence of functional iron deficiency in the study population using full blood count, reticulocytes, transferrin saturation, serum-ferritin, CRP and ALAT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary endpoint is the collection of data on quality of life using FACT-An. | through study completion, an average of 1 year | Data on quality of life using FACT-An, which covers a fatigue and anemia subscale, as well as generic QoL domains including physical well-being, functional well-being, emotional well-being and socal well-being subscales - this is done at study entry estimating scores at various subscales of FACT-An. |
Countries
Switzerland
Outcome results
None listed