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

Functional Iron Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333913
• Other study ID #: Kantonsspital_Luzern
• Status: Recruiting
• Start date: February 7, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2022
• Source: Luzerner Kantonsspital
• Contact: Axel Rüfer, MD
• Phone: 0041412055147
• Email: axel.ruefer[@]luks.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Functional Iron Deficiency
• Hematologic Neoplasms

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The secondary endpoint is the collection of data on quality of life using FACT-An.	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.	through study completion, an average of 1 year