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Prevalence Study of Iron Deficiency in Patients With Cancer (CARENFER ONCO)

Primary Purpose

Iron-deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iron deficiency testing
Sponsored by
VIFORFRANCE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Iron-deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Patient hospitalized without consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ONCOLOGY

    Arm Description

    Patient with a cancer

    Outcomes

    Primary Outcome Measures

    Blood iron status
    ferritin, haemoglobin, transferrin saturation factor

    Secondary Outcome Measures

    Full Information

    First Posted
    April 18, 2019
    Last Updated
    April 18, 2019
    Sponsor
    VIFORFRANCE
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03924271
    Brief Title
    Prevalence Study of Iron Deficiency in Patients With Cancer
    Acronym
    CARENFER ONCO
    Official Title
    Prevalence Study of Iron Deficiency in Patients With Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 15, 2019 (Anticipated)
    Primary Completion Date
    June 30, 2019 (Anticipated)
    Study Completion Date
    June 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    VIFORFRANCE

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron-deficiency

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ONCOLOGY
    Arm Type
    Experimental
    Arm Description
    Patient with a cancer
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Iron deficiency testing
    Intervention Description
    Blood sample for complete iron status
    Primary Outcome Measure Information:
    Title
    Blood iron status
    Description
    ferritin, haemoglobin, transferrin saturation factor
    Time Frame
    One day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision Patient hospitalized without consent

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34330792
    Citation
    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. 2021 Jul 30:bmjspcare-2021-002913. doi: 10.1136/bmjspcare-2021-002913. Online ahead of print.
    Results Reference
    derived

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    Prevalence Study of Iron Deficiency in Patients With Cancer

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