Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-09 @ 11:28 AM
Study NCT ID:
NCT03102905
Status:
UNKNOWN
Last Update Posted:
2017-04-06
First Post:
2017-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005076', 'term': 'Exanthema'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-06-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied.', 'timeFrame': '1 day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HHV6', 'Exanthema', 'Hemopathy']}, 'descriptionModule': {'briefSummary': 'To look for the replication of HHV6 by PCR in the skin, in these patients with haemopathies presenting an exanthema. This will make it possible to evaluate the prevalence of the positivity of this PCR in the skin. Then the investigator can investigate whether there is an association between the positivity of HHV6 PCR in the blood and / or skin and the viral etiology of the exanthema. If this association exists, it will make it possible to improve the diagnosis in the context of the exanthema and thus to improve the therapeutic management of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient hospitalized in the Clinical Hematology and Cellular Therapy department of the CHU Amiens-Picardie between 01/01/2011 and 31/01/2016', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Supported for any type of hemopathy.\n* Allograft, autografted or ungrafted haematopoietic stem cells\n* Having presented an exanthema during hospitalization, for which a cutaneous biopsy had been performed\n* Having had a blood test of the HHV6 virus by PCR at least within the previous 40 days or following the rash.\n* Age greater than or equal to 18 years\n* Patient informed of the protocol by post, not having refused within one month of sending the said courier.\n\nExclusion Criteria:\n\n* Patient who refused the search.\n* Patient whose HHV6 PCR in the blood was carried out at a distance of more than 40 days from the skin biopsy.'}, 'identificationModule': {'nctId': 'NCT03102905', 'acronym': 'REPLIPO', 'briefTitle': 'Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?', 'orgStudyIdInfo': {'id': 'PI2016_843_0017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied.', 'type': 'OTHER', 'description': 'To evaluate the prevalence of the positivity of HHV6 PCR in the skin, during the exanthema in patients hospitalized for haemopathy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume CHABY, Dr', 'role': 'CONTACT', 'email': 'chaby.guillaume@chu-amiens.fr', 'phone': '+33322455846'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Guillaume CHABY, Dr', 'role': 'CONTACT', 'email': 'chaby.guillaume@chu-amiens.fr', 'phone': '+33322455846'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}