Iron-deficiencyCarenceMartialNCT04139265
Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency
An observational study of Iron-deficiency and Internal Medicine, run by Lille Catholic University at 1 site in France.
Trial summary
Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Iron-deficiency, Internal Medicine, Transferrin
- What is being tested?
- biologic analysis (ferritinemia, transferrin saturation coefficient)
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2019to 30 Sep 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly people hospitalized in the internal medicine and geriatry service
Who may be able to join
- ≥ 65 years old
- Patient hospitalized in the internal medicine and geriatry service
- Patient affiliated with a social security scheme
- Patient signed an Informed consent
Who cannot join
- Risk benefit balance not in favor of iron deficiency check-up
- Patient in palliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accordance Between Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency, in Patients Hospitalised in Internal Medicine Service and 65 Years Old and More
Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency
- Conditions
- Iron-deficiency, Internal Medicine, Transferrin, Ferritinemia
- Being tested
- biologic analysis (ferritinemia, transferrin saturation coefficient)
- 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.
biologic analysis (ferritinemia, transferrin saturation coefficient)Diagnostic test
Each patient will follow a blood test in order to compare between ferritinemia and transferrin saturation coefficient in iron deficiency diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients aged 65 and over | - Patients aged 65 and over hospitalized in the department of Internal Medicine and Geriatry Receives: Diagnostic Test: biologic analysis (ferritinemia, transferrin saturation coefficient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between Transferrin Saturation Coefficient (TSC) and ferritinemia dosage
The overall agreement, assessed by kappa Cohen
Measured: Day one
Secondary outcomes (3)
Prevalence of iron deficiency with and without anaemia
Number of patients with iron deficiency with or without anaemia
Measured: Day one
Prevalence of etiologies of iron deficiency
Number of patients for each etiology
Measured: Day one
Prevalence of iron deficiency in patients with anticoagulant and platelet aggregation inhibitor
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start6 Jun 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Bulckaen, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139265
- Sponsor's protocol ID
- RC-P0079
- Acronym
- CarenceMartial
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 25 Oct 2019
- 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 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accordance Between Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency, in Patients Hospitalised in Internal Medicine Service and 65 Years Old and More
- ClinicalTrials.gov ID
- NCT04139265
- Acronym / sponsor ID
- CarenceMartial / RC-P0079
- Conditions
- Iron-deficiency, Internal Medicine, Transferrin, Ferritinemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 25 Oct 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.
Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients aged 65 and over | – | Diagnostic Test: biologic analysis (ferritinemia, transferrin saturation coefficient)- Patients aged 65 and over hospitalized in the department of Internal Medicine and Geriatry |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly people hospitalized in the internal medicine and geriatry service
Key inclusion criteria (4 listed)
- ≥ 65 years old
- Patient hospitalized in the internal medicine and geriatry service
- Patient affiliated with a social security scheme
- Patient signed an Informed consent
Key exclusion criteria (2 listed)
- Risk benefit balance not in favor of iron deficiency check-up
- Patient in palliative care
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 |
|---|---|---|
| biologic analysis (ferritinemia, transferrin saturation coefficient)Each patient will follow a blood test in order to compare between ferritinemia and transferrin saturation coefficient in iron deficiency diagnosis | Diagnostic test | Hospitalized patients aged 65 and over |
Primary outcome
Agreement between Transferrin Saturation Coefficient (TSC) and ferritinemia dosage
Time frame: Day one
The overall agreement, assessed by kappa Cohen
3 secondary outcomes
Prevalence of iron deficiency with and without anaemia
Time frame: Day one
Prevalence of etiologies of iron deficiency
Time frame: Day one
Prevalence of iron deficiency in patients with anticoagulant and platelet aggregation inhibitor
Time frame: Day one
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 25 Oct 2019.
- 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.
Hélène Bulckaen, MD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
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 Iron-deficiency and Internal Medicine, run by Lille Catholic University at 1 site in France.
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: finished, as of the sponsor's last update on 25 Oct 2019. 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 France. 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?
Agreement between Transferrin Saturation Coefficient (TSC) and ferritinemia dosage (time frame: Day one). 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 25 Oct 2019.