Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-27 @ 9:26 AM
Study NCT ID:
NCT04249856
Status:
UNKNOWN
Last Update Posted:
2020-01-31
First Post:
2020-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colposcopy and Dynamic Spectral Imaging (DSI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'Cervical punch biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-30', 'studyFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2020-01-30', 'lastUpdatePostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of women found with a histological diagnosis of Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) in colposcopy-directed biopsy (CDB)', 'timeFrame': 'when the histological report is available - typically 4 weeks after the biopsy was taken.', 'description': 'The proportion of women who are found with a histological CIN2+ diagnosis in the cervical punch biopsy from the area chosen by the colposcopist before the DSI-map became visible (will be referred to as the Colposcopy directed biopsy (CDB)).\n\nThe diagnosis of the biopsy will be recorded when the histological report is available.\n\nFurther treatment needs for the patient will be based on the national clinical guidelines on cervical dysplasia.'}, {'measure': 'Proportion of women found with a histological diagnosis of CIN2 or worse in DSI-directed biopsies', 'timeFrame': 'when the histological report is available - typically 4 weeks after the biopsy was taken.', 'description': 'The proportion of women who are found with a histological CIN2+ diagnosis in cervical punch biopsy taken from the worst area indicated by the DSI-map (referred to as the DSI-directed biopsy) The diagnosis of the biopsy will be recorded when the histological report is available.\n\nFurther treatment needs for the patient will be based on the national clinical guidelines on cervical dysplasia.'}, {'measure': 'Proportion of women found with a histological diagnosis of CIN2 or worse in 2 additional random biopsies', 'timeFrame': 'when the histological report is available - typically 4 weeks after the biopsy was taken.', 'description': 'The amount of women who are found with a histological CIN2+ diagnosis in cervical punch biopsies taken from 2 additional areas besides the CDB and the DSI-directed areas.\n\nThe diagnosis of the biopsy will be recorded when the histological report is available.\n\nFurther treatment needs for the patient will be based on the national clinical guidelines on cervical dysplasia.'}], 'secondaryOutcomes': [{'measure': 'Concordance of cervical punch biopsies and cone biopsy', 'timeFrame': 'When both histological reports were available these were compared.', 'description': 'Comparing the histological diagnosis of the cervical punch biopsies to the cone biopsy, in women who are referred for conization based on the histological outcome of the colposcopy procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Colposcopy', 'Dynamic Spectral Imaging, DySIS', 'Colposcopy Directed Biopsy'], 'conditions': ['Cervical Dysplasia', 'Cervical Disease', 'Cervical Lesion', 'Cervix Cancer', 'Cervical Cancer', 'Cervical Neoplasm']}, 'referencesModule': {'references': [{'pmid': '34798899', 'type': 'DERIVED', 'citation': 'Jespersen MM, Booth BB, Petersen LK. Can biopsies be omitted after normal colposcopy in women referred with low-grade cervical cytology? A prospective cohort study. BMC Womens Health. 2021 Nov 19;21(1):394. doi: 10.1186/s12905-021-01537-5.'}, {'pmid': '33435974', 'type': 'DERIVED', 'citation': 'Booth BB, Petersen LK, Blaakaer J, Johansen T, Mertz H, Dahl K, Bor P. Can the dynamic spectral imaging (DSI) color map improve colposcopy examination for precancerous cervical lesions? A prospective evaluation of the DSI color map in a multi-biopsy clinical setting. BMC Womens Health. 2021 Jan 12;21(1):21. doi: 10.1186/s12905-020-01169-1.'}]}, 'descriptionModule': {'briefSummary': "This study evaluates the Dynamic Spectral Imaging (DSI) Colposcope (DySIS) in it's ability to diagnose cervical dysplasia. Half of participants with be examined by the DySIS colposcope, there the other half will be examined by standard colposcopy.", 'detailedDescription': 'Colposcopy has been shown to be a subjective exam, and is dependant on the colposcopists. Sensitivity for colposcopy has been shown to be as low as 50%.\n\nTo improve this, different adjunctive technologies have been introduced to add a more objective approach to the colposcopy exam. One of these devices is the DySIS colposcope, which measures the aceto-white reaction that may occur on the cervix uteri after the application of acetic-acid. The device provides the examiner with a colour-coded map indicating areas of interest. Studies have shown promising results indicating that using this device together with the colposcopists own interpretation of the cervix uteri can potentially lead to an increase in the performance of the colposcopy exam.\n\nIn Denmark all women referred for colposcopy have 4 biopsies taken, according to the Danish national guidelines.\n\nIn our study these 4 biopsies are as following:\n\n1. The area the colposcopists views as the worst before the DSI-map is seen. Colposcopy-Directed Biopsy (CDB)\n2. The area indicated as the worst by the DSI-map (DSI-directed biopsy)\n3. additional biopsy\n4. additional biopsy All biopsies are placed in separate containers and analysed separately by specialized pathologists.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All women above the age of 18 who are referred for colposcopy due to an abnormal cervical smear (ASCUS, LSIL, ASC-H, HSIL, ACG or CIS) or as follow up to previously diagnosed CIN. The women cannot be included if they have had cervical biopsies taken within the last 6 months, have previously had a cone biopsy taken, are currently pregnant or have been pregnant within the last 3 months.', 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred for colposcopy due to a cervical smear test of Atypical Squamous Cells of Undetermined Significance (ASCUS), low-grade intraepithelial lesion (LSIL), atypical squamous cells, cannot exclude a high-grade lesion (ASC-H), high-grade intraepithelial lesion (HSIL), Atypical glandular cells (ACG) or carcinoma in situ (CIS)\n* Referred for colposcopy due to follow-up of previously diagnosed CIN (If there has been a minimum of 6 months since previous cervical biopsies)\n\nExclusion Criteria:\n\n* Cervical biopsies taken within the last 6 months\n* Previous cone procedure\n* Currently pregnant\n* Pregnant within the last 6 months'}, 'identificationModule': {'nctId': 'NCT04249856', 'briefTitle': 'Colposcopy and Dynamic Spectral Imaging (DSI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Does Dynamic Spectral Imaging (DSI) Colposcopy Improve the Diagnostics of Cervical Dysplasia Compared to Standard Colposcopy', 'orgStudyIdInfo': {'id': 'DSIcolposcopy_DK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women examined by colposcopy', 'description': 'Women referred to colposcopy at our facilities who met inclusion criteria', 'interventionNames': ['Diagnostic Test: Dynamic Spectral Imaging (DYSIS)']}], 'interventions': [{'name': 'Dynamic Spectral Imaging (DYSIS)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS)', 'armGroupLabels': ['Women examined by colposcopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8930', 'city': 'Randers', 'state': 'Danmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Berit B Booth', 'role': 'CONTACT', 'email': 'berit.booth@auh.rm.dk', 'phone': '28587858'}], 'facility': 'Randers Regional Hospital', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}, {'zip': '9000', 'city': 'Aalborg', 'status': 'WITHDRAWN', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8000', 'city': 'Aarhus', 'status': 'COMPLETED', 'country': 'Denmark', 'facility': 'Private Gynaecology Clinic', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '8700', 'city': 'Horsens', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christina B Kristensen, MD', 'role': 'CONTACT'}], 'facility': 'Horsens Regional Hospital', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}], 'centralContacts': [{'name': 'Berit B Booth, MD', 'role': 'CONTACT', 'email': 'berit.booth@auh.rm.dk', 'phone': '+4528587858'}], 'overallOfficials': [{'name': 'Berit B Booth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}, {'name': 'Pinar Bor, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Randers Regional Hospital'}, {'name': 'Lone K Petersen, MD, Med.Sc.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Odense University Hospital'}, {'name': 'Jan Blaakaer, MD, Med.Sc.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Odense University Hospital'}, {'name': 'Katja Dahl, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}