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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03924271
Recruitment Status : Not yet recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
VIFORFRANCE

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 Cacoub (unpublished) on the french national health insurance database showed that iron deficiency was an underdiagnosed and under-treated co-morbidity.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)

Condition or disease Intervention/treatment Phase
Iron-deficiency Diagnostic Test: Iron deficiency testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence Study of Iron Deficiency in Patients With Cancer
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: ONCOLOGY
Patient with a cancer
Diagnostic Test: Iron deficiency testing
Blood sample for complete iron status




Primary Outcome Measures :
  1. Blood iron status [ Time Frame: One day ]
    ferritin, haemoglobin, transferrin saturation factor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: VIFORFRANCE
ClinicalTrials.gov Identifier: NCT03924271    
Other Study ID Numbers: CARENFER ONCO HEMATO
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases