Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-03 @ 1:36 PM
Study NCT ID:
NCT07237932
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-20
First Post:
2025-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adenomyosis Imaging,Histo, Clinical
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Classifications of adenomyosis', 'timeFrame': '12 months', 'description': 'Class of adenomyosis according to imaging, histopathology and clinical outcomes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenomyosis']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to identify and compare the results of imaging studies and evaluating adenomyosis features and post hysterectomy results and their clinical relievants as well as to describe classification for adenomyosis based on one or a combination of clinical, imaging and histopathological features.\n\nMain questions it aim to answer:\n\nWhat's the relation between clinical symptoms ,maging and histopathological classification of adenomyosis? Research will identify relationships between clinical symptoms, imaging and histopathological classification of adenomyosis Participants will undergo transvaginal ultrasound, non contrast pelvic MRI, hysterectomy then histopathological examination for their uterus"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patient multipara complete their family who has heavy menstrual bleeding due to adenomyosis with failure of medical treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge from 35 to 55 years old female Multipara women No previous treatment for uterine adenomyosis within three months Women with heavy menstrual bleeding and dysmenorrhoea Women who completed their families Patient failed medical treatment and hysterectomy is the only remaining line for treatment -\n\nExclusion Criteria:\n\nPatients not candidate for hysterectomy Positive pregnancy test Patients with contraindications for MRI such as patients with pacemakers, claustrophobia,or other implanted electronic devices Inadequate image quality due to motion artifact\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07237932', 'acronym': 'adeno I/H/C', 'briefTitle': 'Adenomyosis Imaging,Histo, Clinical', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Classifications of Adenomyosis and Correlation of Phenotypes in Imaging and Histopathology to Clinical Outcomes', 'orgStudyIdInfo': {'id': 'KFSIRH200-573'}}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'country': 'Egypt', 'facility': 'Kafr elsheikh university', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Samaa Kamal Ahmed Hussien', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}