Clincosm LogoSign in Get a demo

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

Sponsor
Luzerner Kantonsspital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05333913
Collaborator
(none)
104
Enrollment
1
Location
17.7
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    104 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence of Functional Iron Deficiency (FID) and Quality of Life (QoL) in Patients With Oncological and With Haematological Malignancies
    Actual Study Start Date :
    Feb 7, 2022
    Anticipated Primary Completion Date :
    Jul 31, 2022
    Anticipated Study Completion Date :
    Jul 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Luzerner Kantonsspital Luzern Switzerland 6000

    Sponsors and Collaborators

    • Luzerner Kantonsspital

    Investigators

    • Study Chair: Axel Ruefer, MD, Abteilung Hämatologie, Luzerner Kantonsspital, 6000 Luzern 16, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Axel Rüfer, MD, Co-Chefarzt Hämatologie, Luzerner Kantonsspital
    ClinicalTrials.gov Identifier:
    NCT05333913
    Other Study ID Numbers:
    • Kantonsspital_Luzern
    First Posted:
    Apr 19, 2022
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hematologic Neoplasms
    Anemia, Iron-Deficiency

    Study Results

    No Results Posted as of Apr 19, 2022