POlycythemia, Proteins and ErYthropoiesis (POPEYE)

March 25, 2025 updated by: Centre Hospitalier Universitaire Dijon
Erythropoiesis encompasses all the stages and mechanisms involved in the production of red blood cells, or erythrocytes, under the control of a large number of regulatory agents, most often proteins. Among these proteins, erythropoietin and interleukin-3 play a major role. Similarly, proteins involved in iron metabolism (erythroferrone, hepcidin, ferroportin, transferrin, ferritin) influence erythrocyte production more or less directly. The regulation of erythropoiesis is a fine, complex mechanism involving a large number of players, not only through the stimulation of hypoxia pathways to control erythropoietin synthesis, but also through the availability of iron, an essential element for erythropoiesis. Excessive erythrocyte production can lead to polycythemia, the causes of which are varied, primary or secondary, acquired or constitutional. The aim of this work is the descriptive study (quantitative and/or qualitative) of the various proteins involved in the regulation of erythropoiesis in patients with polycythemia. These proteins will be measured in the plasma of patients obtained after blood sampling or bloodletting (bloodletting being the most common treatment for polyglobulic patients) and will be compared with the proteins of patients without polycythemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with polycythemia

Description

Inclusion Criteria:

- Persons who have given their non-opposition

Patients with polycythemia:

  • haemoglobin value > 16 g/dl female or > 16.5 g/dl male
  • with a well-identified cause: either primary (polycythemia Vaquez, erythropoietin receptor or LNK/SH2B3 mutation...) or secondary [cardio-respiratory pathologies, renal pathologies (post-transplant, polycystic kidney disease), metabolic pathologies, tumour (leiomyoma, pheochromocytoma...), constitutional mutations (hyperaffine haemoglobins, HIF2/EPAS1, PHD/EGLN1, VHL, ...)

Patients control:

- persons with a similar pathology to that of polycythemia patients, essentialy secondary, but without polycythemia, i.e. with a haemoglobin value of < 16 g/DL for women and < 16.5 g/DL for men

Exclusion Criteria:

  • Person subject to a measure of legal protection (guardianship, tutorship)
  • Person subject to a court order
  • Pregnant, parturient or nursing woman
  • Incapable of expressing consent
  • Minor

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with polycythemia
Whatever the origin of polycythemia
Biological: Collection of tube bottoms from blood samples taken in the clinic
Collection of tube bottoms from blood samples taken in the clinic
Patient controls
Patients with the same pathological features but without polycythemia
Biological: Collection of tube bottoms from blood samples taken in the clinic
Collection of tube bottoms from blood samples taken in the clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of various proteins involved in the regulation of erythropoiesis
Time Frame: at baseline
at baseline

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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 (Actual)

September 1, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIRODON_2024

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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