Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT00193934
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-10', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the prognostic significance, with respect to overall survival, of the factors, FIGO stage. Overall survival is defined as the date of registration to date of death from any cause.', 'timeFrame': 'End of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Women's Health", 'Multidisciplinary, multicentre prospective study', 'Cancer:mechanisms of growth, invasion, metastases', 'Figo Stages cervical cancer', 'Advances in diagnosis using radiological methods', 'Quantitative Magnetic Resonance Imaging', 'Patient Management Strategies', 'Selecting patients for therapy'], 'conditions': ['Cancer of the Uterine Cervix']}, 'referencesModule': {'references': [{'pmid': '14528092', 'type': 'BACKGROUND', 'citation': 'Narayan K, McKenzie A, Fisher R, Susil B, Jobling T, Bernshaw D. Estimation of tumor volume in cervical cancer by magnetic resonance imaging. Am J Clin Oncol. 2003 Oct;26(5):e163-8. doi: 10.1097/01.coc.0000091358.78047.b5.'}, {'pmid': '14675351', 'type': 'BACKGROUND', 'citation': 'Narayan K, McKenzie AF, Hicks RJ, Fisher R, Bernshaw D, Bau S. Relation between FIGO stage, primary tumor volume, and presence of lymph node metastases in cervical cancer patients referred for radiotherapy. Int J Gynecol Cancer. 2003 Sep-Oct;13(5):657-63. doi: 10.1046/j.1525-1438.2003.13026.x.'}, {'pmid': '16014109', 'type': 'BACKGROUND', 'citation': 'Narayan K. Arguments for a magnetic resonance imaging-assisted FIGO staging system for cervical cancer. Int J Gynecol Cancer. 2005 Jul-Aug;15(4):573-82. doi: 10.1111/j.1525-1438.2005.00128.x.'}], 'seeAlsoLinks': [{'url': 'http://www.trog.com.au', 'label': 'Click here for more information about this study on the TROG official website'}]}, 'descriptionModule': {'briefSummary': 'The researchers propose that it may be corpus invasion, rather than tumour volume per se, which is one of the important determinants of ultimate outcome in cervix cancer. The aim of the proposed prospective, multicentre study, is to confirm the results of our retrospective studies, specifically that corpus invasion or tumour volume or both contribute important prognostic information over and above that provided by the currently used International Federation of Gynecology and Obstetrics (FIGO) staging system. A successful outcome would have important implications for the staging, and management as well as the biologic understanding of the behaviour of cervical cancer.', 'detailedDescription': 'This will be a prospective, multicentre, prognostic factor, follow-up study. The study is designed to be as simple as possible: newly diagnosed cervical cancer patients will have key prognostic variables collected at baseline. The treatment received will be documented at the end of treatment and patients will then be followed for first relapse and survival.\n\nRegistration of a patient on this study can be undertaken after EUA, biopsy confirmed diagnosis, anatomic staging diagram and MRI have been done and before any treatment has commenced.\n\nTreatment must be curative in intent (termed radical therapy) but otherwise can be at the discretion of the investigator. Radical hysterectomy alone, hysterectomy followed by adjuvant radiotherapy, radical chemo-radiotherapy or radical radiotherapy will be allowed. Details of the planned and given treatment regimen will be recorded.\n\nAll patients will have the following trial data documented at the time of registration:\n\n* Age\n* ECOG performance status\n* smoking status\n* date of histological diagnosis\n* histologic type and features\n* presenting haemoglobin\n* standard FIGO staging\n* maximum clinical tumour diameter measured at EUA\n* detailed staging diagram drawn at EUA\n* nodal status (by surgical pathology or CT or MRI or both and PET if available)\n* date of MRI\n* MRI tumour diameters\n* presence or absence of corpus invasion on MRI\n* planned treatment details\n\nAll patients will be assessed pre-treatment, immediately following treatment and will be followed up for local control and survival at yearly intervals from the date of registration.\n\nIt is intended to collect follow up information on all patients until one year after the final patient is registered on study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed cervical cancer patients, Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed, biopsy proven carcinoma of the uterine cervix.\n2. Squamous cell, adenocarcinoma, adenosquamous or large cell carcinoma histology.\n3. FIGO Stage Ib -IVa.\n4. Maximum clinical tumour diameter recorded.\n5. MRI done within 30 days prior to registration.\n6. Intention to treat radically\n7. Treatment not yet started.\n8. Written informed consent.\n9. Available for follow-up.\n\nExclusion Criteria:\n\n1. Lymphoma, small cell carcinoma and melanoma histology.\n2. Previous hysterectomy\n3. Pregnancy'}, 'identificationModule': {'nctId': 'NCT00193934', 'briefTitle': 'Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Trans Tasman Radiation Oncology Group'}, 'officialTitle': 'Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer', 'orgStudyIdInfo': {'id': 'TROG 04.02'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Cervical Cancer Patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '1871', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '2298', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Calvary Mater Newcastle', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': '2069', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2145', 'city': 'Wentworthville', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80652, 'lon': 150.96785}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Royal Brisbane Hospital', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4810', 'city': 'Townsville', 'state': 'Queensland', 'country': 'Australia', 'facility': 'North Queensland Oncology Service', 'geoPoint': {'lat': -19.26639, 'lon': 146.80569}}, {'zip': '4224', 'city': 'Tugun', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Premion - Tugun', 'geoPoint': {'lat': -28.15, 'lon': 153.5}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3002', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Tata Memorial Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Tamil Nadu', 'country': 'India', 'facility': 'Meenakshi Mission Hospital'}, {'zip': '1001', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '4710', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Dunedin', 'country': 'New Zealand', 'facility': 'Dunedin Hospital', 'geoPoint': {'lat': -45.87416, 'lon': 170.50361}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Gerard Adams', 'role': 'STUDY_CHAIR', 'affiliation': 'Oceania Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trans Tasman Radiation Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peter MacCallum Cancer Centre, Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rebecca Montgomery', 'investigatorFullName': 'TROG Administrator', 'investigatorAffiliation': 'Trans Tasman Radiation Oncology Group'}}}}