Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-28 @ 8:11 PM
Study NCT ID:
NCT01918969
Status:
UNKNOWN
Last Update Posted:
2013-08-08
First Post:
2013-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reference Values of Circulating Endothelial Progenitor Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-07', 'studyFirstSubmitDate': '2013-08-06', 'studyFirstSubmitQcDate': '2013-08-07', 'lastUpdatePostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14-', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endothelial progenitor cells', 'Healthy blood donors'], 'conditions': ['Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '21481600', 'type': 'BACKGROUND', 'citation': 'Parietti E, Pallandre JR, Deschaseaux F, Aupecle B, Durst C, Kantelip JP, Chocron S, Davani S. Presence of circulating endothelial progenitor cells and levels of stromal-derived factor-1alpha are associated with ascending aorta aneurysm size. Eur J Cardiothorac Surg. 2011 Jul;40(1):e6-12. doi: 10.1016/j.ejcts.2011.02.065. Epub 2011 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. However reference values have not yet been determined. This study is aimed to determine reference values of CD34+144+CD14- et CD34+VEGF-R2+CD14- in healthy men and women blood donors.', 'detailedDescription': 'At the time of blood donation, 10mL of blood will be used to calculate the concentration of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- , and the ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells in order to determine reference values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy blood donors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Blood donors\n\nExclusion Criteria:\n\n* age over 65\n* Arterial hypertension (treated or not)\n* Vascular disease\n* smoker or former smoker who stopped smoking for less than a year'}, 'identificationModule': {'nctId': 'NCT01918969', 'acronym': 'ANOPEC2', 'briefTitle': 'Reference Values of Circulating Endothelial Progenitor Cells', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Jean Minjoz'}, 'officialTitle': 'Determination of Reference Values of Circulating Endothelial Progenitor Cells CD34+144+CD14- and CD34+VEGF-R2+CD14- in a Blood Donnor Population', 'orgStudyIdInfo': {'id': '13/408'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blood donors', 'description': 'Blood donors with no exclusion criteria i.e with a very low probability to have an aortic aneurysm'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'contacts': [{'name': 'Sidney Chocron, MD, PhD', 'role': 'CONTACT', 'email': 'sidney.chocron@univ-fcomte.fr', 'phone': '+33381533121'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Sidney Chocron, MD, PhD', 'role': 'CONTACT', 'email': 'sidney.chocron@univ-fcomte.fr', 'phone': '+33381533121'}, {'name': 'Sidney Chocron, MD,PhD', 'role': 'CONTACT', 'email': 'sidney.chocron@univ-fcomte.fr', 'phone': '+33381533121'}], 'overallOfficials': [{'name': 'Andrea Perrotti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Franche-Comte; France'}, {'name': 'Pascal Morel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Etablissement Français du Sang'}, {'name': 'Siamak Davani, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Franche-Comte. france'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Jean Minjoz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Prof. Sidney Chocron', 'investigatorAffiliation': 'Hopital Jean Minjoz'}}}}