Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-02 @ 3:46 AM
Study NCT ID:
NCT03136757
Status:
UNKNOWN
Last Update Posted:
2017-07-21
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-04-28', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcriptomic profile by analysis of the expression of the mRNAs of a determined panel of 800 genes regulating the immune response', 'timeFrame': '3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Graft Vs Host Disease', 'Hematopoietic Stem Cells']}, 'descriptionModule': {'briefSummary': 'Graft-versus-host disease (GVHD) is a frequent and severe complication of hematopoietic stem cell transplantation (HSC), and is responsible for significant early mortality despite prophylactic strategies developed in recent decades, Especially since it is resistant to first-line treatment.\n\nThe present diagnosis is difficult, non-specific and is based on the combination of an evocative clinical context (CSH allograft, time to appearance before J100, characteristic clinical manifestations), suggestive anatomo-pathological analysis (predominantly inflammatory infiltrate Lymphocyte, mucosal edema and presence of apoptotic bodies), and the exclusion of any differential diagnosis (in particular serology / negative viral PCR).\n\nHowever, to date there is no molecular characterization of this manifestation, and therefore no specific treatment.\n\nThe nCounter® nanostring technology allows the rapid and simple analysis of the simultaneous expression of a group of genes (up to 800 on the same sample), from a very small amount of RNA, and from samples with difficulty Such as fabrics already fixed to formaldehyde and included in paraffin. It allows the detection of a "molecular signature" of the tissue analyzed.\n\nNo transcriptomic analysis has ever been performed on human tissues with GVHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recovery of fixed and paraffin-embedded biopsy fragments previously performed during the diagnosis of GVHD, not used for routine histological analysis because in excess, and stored in the pathology laboratory', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person aged ≥ 18 years\n* Patients who have received an HSC allograft since June 2012\n* Having presented a suspicion of cutaneous or digestive GVHD before J100 post-allograft\n* Of which the diagnosis was retained by the combination of clinical and histological criteria\n* Or whose diagnosis has been reversed by histological analysis, for the reactive / inflammatory biopsies that serve as control\n* The diagnosis of which was made between 01/01/2013 and 31/12/2015\n* Survived at least 1 month to monitor clinical progress\n\nExclusion Criteria:\n\n* Whose biopsy specimens were also the sites of a viral reactivation (EBV, CMV, HHV) that could mimic a GVHD\n* Having survived less than 1 month after the diagnosis of GVHD'}, 'identificationModule': {'nctId': 'NCT03136757', 'briefTitle': 'Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells', 'orgStudyIdInfo': {'id': 'PI2016_843_0016'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcriptomic analysis of GVHD biopsies', 'type': 'OTHER', 'description': 'The transcriptomic analysis of GVHD biopsies aims at:\n\n* to demonstrate an evocative or even specific molecular profile, making the diagnosis of GVHD easier\n* to identify new intracellular signaling pathways that could lead to new therapeutic'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Pierre MAROLLEAU, PhD', 'role': 'CONTACT', 'email': 'marolleau.jean-pierre@chu-amiens.fr', 'phone': '+33322455914'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Jean-Pierre MAROLLEAU, PhD', 'role': 'CONTACT', 'email': 'marolleau.jean-pierre@chu-amiens.fr', 'phone': '+33322455914'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}