Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2026-01-09 @ 10:29 PM
Study NCT ID:
NCT05374720
Status:
UNKNOWN
Last Update Posted:
2023-06-18
First Post:
2022-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002925', 'term': 'Ciliary Motility Disorders'}, {'id': 'D011271', 'term': 'Pregnancy, Ectopic'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058994', 'term': 'Salpingectomy'}, {'id': 'D007044', 'term': 'Hysterectomy'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-05-13', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphological of tubal cilia', 'timeFrame': 'through study completion, an average of 6 week after surgery', 'description': 'Molecular compositor of tubal ciliar by immunofluorescence study of 14 proteins in vivo and in vitro (tissue cells from patient fallopian tubes)'}, {'measure': 'Molecular difference in tubal cilia between patients with or without GEU salpingectomy', 'timeFrame': 'through study completion, an average of 6 week after surgery', 'description': 'compares molecular compositor of tubal ciliar by immunofluorecence study of 14 proteins in vivo and in vitro between patients with or without GEU salpingectomy'}, {'measure': 'molecular tubal cilia', 'timeFrame': 'through study completion, an average of 6 week after surgery', 'description': 'Ultrastructure morphology of tubal cell cilia by electron microscopy'}, {'measure': 'functional composition of tubal cell by video microscopy', 'timeFrame': 'through study completion, an average of 6 week after surgery', 'description': 'amplitude of moment by video microscopy'}, {'measure': 'functional composition of tubal cell by video microscopy', 'timeFrame': 'through study completion, an average of 6 week after surgery', 'description': 'frequency of moment by video microscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['miscarriage', 'tubal cilia'], 'conditions': ['Salpingectomy', 'Hysterectomy', 'Primary Ciliary Dyskinesia', 'Ectopic Pregnancy']}, 'descriptionModule': {'briefSummary': 'Primary Ciliary Dyskinesia associated with abnormalities of lateralization of organs (with existence of a situs inversus in 50% of cases) and secondary fertility disorders related in humans to abnormalities of mobility of sperm but very little data on the structure and function of tubal cilia in women', 'detailedDescription': 'Primary Ciliary Dyskinesia (DCP) is a rare genetic disease (1 in 15,000 individuals at birth), which manifests itself in chronic respiratory infections (bronchopneumopathies and rhinosinusitis type) associated with abnormalities of lateralization of organs (with existence of a situs inversus in 50% of cases) and secondary fertility disorders related in humans to abnormalities of sperm mobility. However, there is very little data in the literature on the structure and function of tubal cilia in women with DCP.\n\nBefore considering a study of tubal cilia in patients with DCP, it seems necessary to specify in DCP patients or not DCP, the molecular and morphological composition of tubal cilia and to look for ciliary abnormalities in case of GEU'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with scheduled salpingectomy (Ectopic pregnancy, hysterectomy for prolapsus, adenomyosis or myomectomy)\n* Major patients ( \\>18 years)\n\nExclusion Criteria:\n\n* Patient not willing to participate in the study'}, 'identificationModule': {'nctId': 'NCT05374720', 'acronym': 'CILTUBE', 'briefTitle': 'Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy', 'orgStudyIdInfo': {'id': 'CILTUBE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salpingectomy for Extra-Uterine Pregnancy', 'description': 'patients with salpingectomy for Ectopic Pregnancy', 'interventionNames': ['Procedure: salpingectomy']}, {'type': 'SHAM_COMPARATOR', 'label': 'hysterectomies', 'description': 'patients with hysterectomy for prolapsus, adenomyosis or myomectomy', 'interventionNames': ['Procedure: hysterectomy']}], 'interventions': [{'name': 'salpingectomy', 'type': 'PROCEDURE', 'description': 'Removal of one of the fallopian tubes.', 'armGroupLabels': ['Salpingectomy for Extra-Uterine Pregnancy']}, {'name': 'hysterectomy', 'type': 'PROCEDURE', 'description': 'remove the uterus, whole or only part. It may also involve the removal of the cervix, ovaries, fallopian tubes and other surrounding structures.', 'armGroupLabels': ['hysterectomies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'state': 'Val-deMarne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rana i MITRI-FRANGIEH', 'role': 'CONTACT', 'email': 'rana.mitri-frangieh@chicreteil.fr', 'phone': '+33157022286'}], 'facility': 'Centre Hospitalier Intercommunal Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Rana MITRI- FRANGIEH', 'role': 'CONTACT', 'email': 'rana.mitri-frangieh@chicreteil.fr', 'phone': '+33 01 57 02 22 86'}, {'name': 'Camille Jung', 'role': 'CONTACT', 'email': 'camille.jung@chicreteil.fr'}], 'overallOfficials': [{'name': 'Rana i MITRI-FRANGIEH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Intercommunal Créteil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}