Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT01690858
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2011-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-14', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2012-09-19', 'lastUpdatePostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mutations in genes coding for molecules that modulate complement activity', 'timeFrame': 'day1 (at inclusion)', 'description': 'to determine frequency of mutations of genes (membrane-cofactor protein (MCP), decay accelerating factor (DAF), ....) involved in complement activation : Profiles of these genes will be analysed in blood sample of females with medical history of repeated foetal losses and compared to those analysed in blood sample of females without medical history of repeated foetal losses.'}], 'secondaryOutcomes': [{'measure': 'serum levels of sFlt1 and endoglin and their link to complement activation markers', 'timeFrame': '4 weeks post pregnancy start', 'description': 'To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.'}, {'measure': 'serum levels of sFlt1 and endoglin and their link to complement activation', 'timeFrame': '8 weeks post pregnancy start', 'description': 'To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.'}, {'measure': 'serum levels of sFlt1 and endoglin and their link to complement activation', 'timeFrame': '16 weeks post pregnancy start', 'description': 'To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.'}, {'measure': 'serum levels of sFlt1 and endoglin and their link to complement activation', 'timeFrame': '24 weeks post pregnancy start', 'description': 'To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Foetal loss', 'complement', 'antiangiogenic factors', 'Repeated fetal losses'], 'conditions': ['Fetal Losses']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the role of complement dysregulation and its impact on antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.', 'detailedDescription': 'Females with medical history of repeated foetal losses will have blood sampling to perform analyses. If pregnant, blood sampling will be performed at different times throughout the pregnancy.\n\nControls will be females without medical history of repeated foetal losses. They will also have blood sampling to perform analyses. If pregnant, blood sampling will be performed at different times throughout the pregnancy.\n\nBlood analyses will focus on :\n\n* mutations in genes coding for molecules that modulate complement activity\n* serum levels of sFlt1 and endoglin and their link to complement activation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females with medical history of repeated foetal losses and females without medical history of repeated foetal losses as controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for females with repeated fetal losses:\n* Age\\> 18\n* Female affiliated to French health insurance (Social Security),\n* Informed consent form signed\n* Patient with history of at least three foetal losses without any cause found (chromosomal abnormalities, uterine malformations, endocrine disorders, etc.)\n\nExclusion criteria for females with repeated fetal losses :\n\n* Patient not fulfilling inclusion criteria\n* Age \\> 40\n* Female unable to understand benefits and risks of protocol\n* Female with history of repeated foetal losses of infectious or endocrine origin.\n\nInclusion criteria for females without repeated fetal losses:\n\n* Age\\> 18\n* Female affiliated to the French health insurance (Social Security)\n* Informed consent form signed\n* Female without history of repeated foetal losses\n\nExclusion criteria for females without repeated fetal losses:\n\n* Patient not fulfilling inclusion criteria\n* Female with age above 40\n* Female unable to understand benefits and risks of protocol'}, 'identificationModule': {'nctId': 'NCT01690858', 'briefTitle': 'Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions', 'orgStudyIdInfo': {'id': '10/6-K'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'females with medical history of repeated foetal losses', 'description': 'The females can be pregnant', 'interventionNames': ['Other: blood sample']}, {'label': 'females without medical history of repeated foetal losses', 'description': 'The females can be pregnant', 'interventionNames': ['Other: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'OTHER', 'description': 'blood sampling at inclusion and throughout pregnancy when pregnant', 'armGroupLabels': ['females with medical history of repeated foetal losses', 'females without medical history of repeated foetal losses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'France', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': 'Antoine Beclere Hospital (AP-HP)', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}