Iron-deficiencyCARENFER ONCONCT03924271
Prevalence Study of Iron Deficiency in Patients With Cancer
A study testing Iron deficiency testing in people with Iron-deficiency, run by VIFORFRANCE.
Trial summary
Despite its high prevalence, a recent study conducted by Prof. Cacoub (unpublished) on the french national health insurance database showed that iron deficiency was an underdiagnosed and under-treated co-morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Iron deficiency testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2019to 30 Jun 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patient, male or female, over the age of 18
- Patient in an oncology department (any type of tumor, any type of treatment, initiated or not)
- Patient affiliated or beneficiary of a social security system
- Patient with written consent
Who cannot join
- Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Patient hospitalized without consent
About this study
Despite its high prevalence, a recent study conducted by Prof. Cacoub (unpublished) on the french national health insurance database showed that iron deficiency was an underdiagnosed and under-treated co-morbidity. In inflammatory situations, especially during cancer, the measurement of the transferrin saturation factor is only performed in about 10% of cases whereas this measure is recommended in inflammatory situations including cancer (French Health High Authority 2011)
- Conditions
- Iron-deficiency
- Being tested
- Iron deficiency testing
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron deficiency testingDiagnostic test
Blood sample for complete iron status
| Study group | Role | What they receive |
|---|---|---|
| ONCOLOGY | Experimental | Patient with a cancer Receives: Diagnostic Test: Iron deficiency testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood iron status
ferritin, haemoglobin, transferrin saturation factor
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start15 May 2019 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIFORFRANCE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924271
- Sponsor's protocol ID
- CARENFER ONCO HEMATO
- Acronym
- CARENFER ONCO
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2019
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luporsi E, Turpin A, Massard V, Morin S, Chauffert B, Carnot A, Cacoub P; Behalf of the CARENFER Study Group. Iron deficiency in patients with cancer: a prospective cross-sectional study. BMJ Support Palliat Care. 2024 May 17;14(2):215-221. doi: 10.1136/bmjspcare-2021-002913.
PubMed 34330792
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Study of Iron Deficiency in Patients With Cancer
- ClinicalTrials.gov ID
- NCT03924271
- Acronym / sponsor ID
- CARENFER ONCO / CARENFER ONCO HEMATO
- Conditions
- Iron-deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- VIFORFRANCEIndustry (pharma, biotech, devices)
- Study start
- 15 May 2019 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 23 Apr 2019 (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.
Despite its high prevalence, a recent study conducted by Prof. Cacoub (unpublished) on the french national health insurance database showed that iron deficiency was an underdiagnosed and under-treated co-morbidity. In inflammatory situations, especially during cancer, the measurement of the transferrin saturation factor is only performed in about 10% of cases whereas this measure is recommended in inflammatory situations including cancer (French Health High Authority 2011)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONCOLOGY | Experimental | Diagnostic Test: Iron deficiency testingPatient with a cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient, male or female, over the age of 18
- Patient in an oncology department (any type of tumor, any type of treatment, initiated or not)
- Patient affiliated or beneficiary of a social security system
- Patient with written consent
Key exclusion criteria (2 listed)
- Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Patient hospitalized without consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron deficiency testingBlood sample for complete iron status | Diagnostic test | ONCOLOGY |
Primary outcome
Blood iron status
Time frame: One day
ferritin, haemoglobin, transferrin saturation factor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Derived from this study: PubMed 34330792Luporsi E, Turpin A, Massard V, Morin S, Chauffert B, Carnot A, Cacoub P; Behalf of the CARENFER Study Group. Iron deficiency in patients with cancer: a prospective cross-sectional study. BMJ Support Palliat Care. 2024 May 17;14(2):215-221. doi: 10.1136/bmjspcare-2021-002913.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Iron deficiency testing in people with Iron-deficiency, run by VIFORFRANCE.
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 2 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: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Blood iron status (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924271, which also lists 1 linked publication.
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 23 Apr 2019.