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

NCT05333913 | Completed

• 1 other identifier: Kantonsspital_Luzern
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Iron Deficiency

Outcome Measures

Primary Outcomes (1)

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

  Prevalence of functional iron deficiency in the study population using full blood count, reticulocytes, transferrin saturation, serum-ferritin, CRP and ALAT.

  through study completion, an average of 1 year

Secondary Outcomes (1)

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

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Study Officials

• Axel Ruefer, MD

  Hematology Department, Luzerner Kantonsspital, 6000 Luzern 16, Switzerland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Head Physician

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 19, 2022
• Study Start: February 7, 2022
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: March 28, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)