Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-30 @ 4:47 PM
Study NCT ID:
NCT04628169
Status:
COMPLETED
Last Update Posted:
2024-09-20
First Post:
2020-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Netrin-1 in the Pathophysiology of Placenta Accreta Spectrum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'impact of netrin-1 in the pathophysiology of placenta accreta spectrum', 'timeFrame': 'baseline', 'description': '1. Evaluation of the immunohistochemical expression of netrin 1 in PAS specimens in comparison with the control placental tissues.\n2. Evaluation of the immunohistochemical expression of neogenin in PAS specimens in comparison with the control placental tissues\n3. Evaluation of the immunohistochemical expression of ZEB1 in PAS specimens in comparison with the control placental tissues.\n4. Correlate their immunohistochemical expression with the demographic parameters and assess the correlation between their expression in PAS specimens.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Netrin-1, neogenin,PAS, zeb-1'], 'conditions': ['Pathophysiology of Placenta Accreta']}, 'descriptionModule': {'briefSummary': 'The main goal of this study is to assess the role of Netrin 1, neogenin and ZEB1 in PAS-associated invasion', 'detailedDescription': '* To evaluate the immunohistochemical expression of these proteins in PAS specimens in comparison with the control placental tissues.\n* To correlate their expression with the demographic parameters.\n* To assess the correlation between their expression in PAS specimens.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 PAS specimens and 30 placental specimens from matched control.', 'healthyVolunteers': True, 'eligibilityCriteria': 'inclusion criteria\n\n* PAS patients who underwent hysterectomy to allow proper pathologic grading of PAS\n\nexclusion criteria\n\n* patients with fundal and middle anterior or posterior placenta,\n* pregnancy associated with morbid conditions such as hypertension, diabetes mellitus, autoimmune disease, cardiac disease, renal disease, history of anemia, blood transfusion, other blood diseases and endocrinal disease; fetal distress or intrauterine growth retardation.\n* uterine scar pregnancies were excluded'}, 'identificationModule': {'nctId': 'NCT04628169', 'briefTitle': 'Impact of Netrin-1 in the Pathophysiology of Placenta Accreta Spectrum', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Netrin-1 in the Pathophysiology of Placenta Accreta Spectrum', 'orgStudyIdInfo': {'id': 'netrin-1 in placenta accreta'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group A', 'description': '30 placental specimens of PAS', 'interventionNames': ['Other: no intervention applied']}, {'label': 'group B', 'description': '30 placental specimens of heaithy women with normal pregnancy', 'interventionNames': ['Other: no intervention applied']}], 'interventions': [{'name': 'no intervention applied', 'type': 'OTHER', 'description': 'no intervention applied', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Hanaa Mohammed Mohammed Sayed', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Hanaa Mohammed Mohammed Sayed', 'investigatorAffiliation': 'Assiut University'}}}}