NCT03924271

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 Cacoub (unpublished) on the french national health insurance database showed that iron deficiency was an underdiagnosed and under-treated co-morbidity.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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 18, 2019

Last Update Submit

April 18, 2019

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (1)

  • Blood iron status

    ferritin, haemoglobin, transferrin saturation factor

    One day

Study Arms (1)

ONCOLOGY

EXPERIMENTAL

Patient with a cancer

Diagnostic Test: Iron deficiency testing

Interventions

Iron deficiency testingDIAGNOSTIC_TEST

Blood sample for complete iron status

ONCOLOGY

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34330792DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

April 23, 2019

Study Start

May 15, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share