Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-31 @ 12:40 PM
Study NCT ID:
NCT06487767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Validity of the Use of Imaging in Cervical Cancer Staging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity', 'timeFrame': '2 years', 'description': 'Metrics of imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical cancer', 'Ultrasound', 'MRI', 'CT Scan', 'PET-CT scan'], 'conditions': ['Cervical Cancer Stage, Imaging Modalities']}, 'descriptionModule': {'briefSummary': 'The study wil aim to investigate the accuracy of imaging in the staging of women diagnosed with cervical cancer', 'detailedDescription': 'Patients with cervical cancer undergoing surgery will also undergo PET-CT scan, CT scan, trans-abdominal ultrasound of the pelvis and abdomen to assess pelvic and para-aortic lymph node status, MRI and trans-vaginal ultrasound (TVUS) to assess tumour size and parametrial infiltration. As per the current unit protocol, patients will be assessed clinically for operability. The performance of the different imaging modalities will be measured against the histological status of the parametric and lymph nodes and tumour size as measured by the pathologists.\n\nCT, PET-CT, MRI and abdominal ultrasound will be reported as per the usual departmental process. Staff in the radiology department will be blinded for the different imaging modalities performed. TVUS will be performed in the unit by different gynaecological oncologists and fellows and at the time of the investigation will be blinded with regards to clinical findings and the reports of other imaging studies performed.\n\nThe sensitivity, specificity, positive and negative predictive values will be calculated for the different imaging modalities.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women diagnosed with cervical cancer scheduled for surgical treatment or intervention', 'genderDescription': 'Women diagnosed with cervical cancer', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Women diagnosed with cervical cancer Able and willing to provide informed consent\n\nExclusion Criteria:\n\nPreviously treated for cervical cancer Unable to provide informed consent Patients with contra-indications to undergo surgical treatment\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06487767', 'briefTitle': 'The Validity of the Use of Imaging in Cervical Cancer Staging', 'organization': {'class': 'OTHER', 'fullName': 'University of Pretoria'}, 'officialTitle': 'The Validity of the Use of Imaging in Cervical Cancer Staging', 'orgStudyIdInfo': {'id': '704/2023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Surgery', 'type': 'OTHER', 'description': 'Surgery for operable cervical cancer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Kalafong Provincial Tertiary Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}], 'centralContacts': [{'name': 'Edwin F Mnisi, MMed (O&G)', 'role': 'CONTACT', 'email': 'edwinmnisi@hotmail.com', 'phone': '+27766129797'}, {'name': 'Leon C Snyman, PhD', 'role': 'CONTACT', 'email': 'leon.snyman@up.ac.za', 'phone': '+27834621818'}], 'overallOfficials': [{'name': 'Cathy Visser, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Trial administrator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pretoria', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr Edwin Mnisi', 'class': 'UNKNOWN'}, {'name': 'Prof Mike Sathekge', 'class': 'UNKNOWN'}, {'name': 'Prof N Khan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Leon Snyman', 'investigatorAffiliation': 'University of Pretoria'}}}}