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Completed

NCT Number: NCT05333913

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The primary endpoint is the determination of the prevalence of FID in patients with oncological and with haematological malignancies.

    Time frame: 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 outcomes

  1. The secondary endpoint is the collection of data on quality of life using FACT-An.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Official study title

Prevalence of Functional Iron Deficiency (FID) and Quality of Life (QoL) in Patients with Oncological and with Haematological Malignancies

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2022
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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