Functional Iron DeficiencyNCT05333913
Prevalence of FID and QoL in Patients with Oncological and with Haematological Malignancies
An observational study of Functional Iron Deficiency, run by Luzerner Kantonsspital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Iron Deficiency
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Feb 2022to 4 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Functional Iron Deficiency (FID) and Quality of Life (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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start7 Feb 2022
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Rüfer, MD, Luzerner Kantonsspital
- Investigators
- Axel Ruefer, MD, Study chair, Hematology Department, Luzerner Kantonsspital, 6000 Luzern 16, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333913
- Sponsor's protocol ID
- Kantonsspital_Luzern
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Functional Iron Deficiency (FID) and Quality of Life (QoL) in Patients with Oncological and with Haematological Malignancies
- ClinicalTrials.gov ID
- NCT05333913
- Acronym / sponsor ID
- Kantonsspital_Luzern
- Conditions
- Functional Iron Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Functional Iron Deficiency
Not yet recruitingPhase 4
IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency
Heart Failure With Preserved Ejection Fraction, Iron Deficiency
RecruitingObservational study
Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders
Bleeding Disorders, Iron
RecruitingPhase 4
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
Chronic Heart Failure, Iron Deficiency, Latent
RecruitingPhase 4
The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension
Pulmonary Hypertension, Iron Deficiency
RecruitingPhase 4
Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation
Aortic Valve Stenosis, Iron Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Ruefer, MD study chair
Hematology Department, Luzerner Kantonsspital, 6000 Luzern 16, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Iron Deficiency, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.