Prevalence of FID and QoL in Patients With Oncological and With Haematological Malignancies

• Conditions: Functional Iron Deficiency

• Registration Number: NCT05333913
• Lead Sponsor: Luzerner Kantonsspital

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.

Study Timeline

• Study Start: 2022-02-07
• Status Verified: 2022-04
• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-16
• Last Update Submitted: 2022-04-16
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19
• Primary Completion: 2022-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland