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

NCT ID: NCT05333913

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2023-04-04

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.

Conditions

Functional Iron Deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luzerner Kantonsspital

OTHER

Sponsor Role: lead

Responsible Party

Axel Rüfer, MD

Co-Head Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Axel Ruefer, MD

Role: STUDY_CHAIR

Hematology Department, Luzerner Kantonsspital, 6000 Luzern 16, Switzerland

Locations

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, Switzerland

Countries

Switzerland

Other Identifiers

Kantonsspital_Luzern

Identifier Type: -

Identifier Source: org_study_id