Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-28 @ 4:03 PM
Study NCT ID:
NCT05815992
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of the Characterization of Adnexal Masses, Indeterminate at Ultrasonography, Using a MRI Protocol Without Contrast: Validation of the Cambridge Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 370}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of generalizability of the Cambridge Score through external validations', 'timeFrame': 'Through study completion, an average of 3 years'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Cambridge Score when diagnosed by different readers', 'timeFrame': 'Through study completion, an average of 3 years'}, {'measure': 'Evaluation of diagnostic agreement between the Non-contrast and contrast-enhanced MRI', 'timeFrame': 'Through study completion, an average of 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adnexal Mass']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective observational study is to evaluate the accuracy and to validate the Cambridge Score,a Test Index to predict the malignancy of the ovarian lesions on the basis of an MRI examination without contrast'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of indeterminate adnexal masses after ultrasonography that will undergo to an MRI examination can be included in this study', 'genderDescription': 'Only women with indeterminate adnexal masses can be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years;\n* Indeterminate adnexal masses at the ultrasonography;\n* Signed Informed Consent.\n\nExclusion Criteria:\n\n* Diagnosis of an extraovary mass;\n* Synchronous tumors;\n* Previous history of neoplasy.'}, 'identificationModule': {'nctId': 'NCT05815992', 'acronym': 'CAMBRIDGE', 'briefTitle': 'Accuracy of the Characterization of Adnexal Masses, Indeterminate at Ultrasonography, Using a MRI Protocol Without Contrast: Validation of the Cambridge Score', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Accuracy of the Characterization of Adnexal Masses, Indeterminate at Ultrasonography, Using a Magnetic Resonance Imaging Protocol Without Contrast: Validation of the Cambridge Score', 'orgStudyIdInfo': {'id': '4298'}}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giacomo G Avesani, MD', 'role': 'CONTACT', 'email': 'giacomo.avesani@policlinicogemelli.it', 'phone': '0630156054', 'phoneExt': '+39'}], 'facility': 'Fondazione Policlinico Universitaro "A. Gemelli" IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}