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

April 18, 2019 updated by: VIFORFRANCE
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 Cacoub (unpublished) on the french national health insurance database showed that iron deficiency was an underdiagnosed and under-treated co-morbidity.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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONCOLOGY
Patient with a cancer
Diagnostic test: Iron deficiency testing
Blood sample for complete iron status

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood iron status
Time Frame: One day
ferritin, haemoglobin, transferrin saturation factor
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIFORFRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2019

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARENFER ONCO HEMATO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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