Clinical trial NCT05333913: Prevalence of FID and QoL in Patients with Oncological and with Haematological Malignancies
Official title: Prevalence of Functional Iron Deficiency (FID) and Quality of Life (QoL) in Patients with Oncological and with Haematological Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Iron Deficiency
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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)

Study entry within four weeks prior to disease-directed systemic therapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint is the determination of the prevalence of FID in patients with oncological and with haematological malignancies.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The secondary endpoint is the collection of data on quality of life using FACT-An.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Hematology Department, Luzerner Kantonsspital, 6000 Luzern 16, Switzerland
name: Axel Ruefer, MD
role: STUDY_CHAIR
References: