Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-31 @ 11:02 AM
Study NCT ID:
NCT06905106
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POlycythemia, Proteins and ErYthropoiesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of various proteins involved in the regulation of erythropoiesis', 'timeFrame': 'at baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erythropoiesis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with polycythemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Persons who have given their non-opposition\n\nPatients with polycythemia:\n\n* haemoglobin value \\> 16 g/dl female or \\> 16.5 g/dl male\n* 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, ...)\n\nPatients control:\n\n\\- 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\n\nExclusion Criteria:\n\n* Person subject to a measure of legal protection (guardianship, tutorship)\n* Person subject to a court order\n* Pregnant, parturient or nursing woman\n* Incapable of expressing consent\n* Minor'}, 'identificationModule': {'nctId': 'NCT06905106', 'acronym': 'POPEYE', 'briefTitle': 'POlycythemia, Proteins and ErYthropoiesis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'POlycythemia, Proteins and ErYthropoiesis', 'orgStudyIdInfo': {'id': 'GIRODON_2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with polycythemia', 'description': 'Whatever the origin of polycythemia', 'interventionNames': ['Biological: Collection of tube bottoms from blood samples taken in the clinic']}, {'label': 'Patient controls', 'description': 'Patients with the same pathological features but without polycythemia', 'interventionNames': ['Biological: Collection of tube bottoms from blood samples taken in the clinic']}], 'interventions': [{'name': 'Collection of tube bottoms from blood samples taken in the clinic', 'type': 'BIOLOGICAL', 'description': 'Collection of tube bottoms from blood samples taken in the clinic', 'armGroupLabels': ['Patient controls', 'Patients with polycythemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François GIRODON', 'role': 'CONTACT', 'email': 'francois.girodon@chu-dijon.fr', 'phone': '0380295710'}], 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'François GIRODON', 'role': 'CONTACT', 'email': 'francois.girodon@chu-dijon.fr', 'phone': '0380295710'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}