NCT04779840

Brief Summary

The incidence of anemia ranges from 20 to 75% depending on the type of cancer. It is often present at diagnosis and increases with specific treatments. It has an impact on overall survival and quality of life. Its origins are multiple (pure iron deficiency or functional, malnutrition, dyserythropoiesis, insufficiency renal, hemolysis, chemotherapy, radiotherapy, targeted therapies). Transfusion is the most common treatment offered in the management of anemia. The incidence of anemia and its consequences are often underestimated during cancer management. Recommendations were published in 2012. An inventory of the incidence of anemia before and after the publication of these recommendations are proposed in order to assess their impact on daily practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
349

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 26, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 26, 2021

Last Update Submit

February 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of anemia

    number of patient with anemia (\<11.0 g/dL) upon admission to hospital on the number of patients hospitalized over the period

    2 years

Secondary Outcomes (5)

  • Assessment of transfusion prescriptions

    2 years

  • Assessment of erythropoiesis stimulating agents (EPO) prescriptions

    2 years

  • Assessment of iron prescriptions

    2 years

  • Time between last transfusion and date of death

    2 years

  • overall survival

    2 years

Study Arms (2)

period 2011

Other: anemia assessment

period 2018

Other: anemia assessment

Interventions

evaluation of anemia status

period 2011period 2018

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with cancer and justifying continuous hospitalization for more than one night regardless of pattern. Patient informed and not having expressed opposition to the study.

You may qualify if:

  • Age ≥ 18 years old,
  • Follow-up for cancer justifying hospitalization,
  • Presenting anemia defined by a hemoglobin level \<11 g / dL,
  • Patient not having objected to the collection of his data after oral and written information.

You may not qualify if:

  • patients with a hemoglobin level ≥ 11 g / dL,
  • adult patients under guardianship, curatorship or deprived of liberty,
  • pregnancy or breast-feeding in progress at the time of hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Jean Bernard - Clinique Victor Hugo

Le Mans, 72000, France

Location

MeSH Terms

Conditions

AnemiaNeoplasms

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Katell LE DÛ, MD

    Centre Jean Bernard/Clinique Victor Hugo - LE MANS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 3, 2021

Study Start

May 20, 2020

Primary Completion

January 20, 2021

Study Completion

January 20, 2021

Last Updated

March 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations