Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-29 @ 1:10 PM
Study NCT ID:
NCT00602368
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2008-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], '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': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D003127', 'term': 'Colposcopy'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2008-01-25', 'studyFirstSubmitQcDate': '2008-01-25', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of digital colposcopy & fluorescence spectroscopy as a tool for early diagnosis of CIN', 'timeFrame': 'For length of study', 'description': 'Measure normal and abnormal sites during colposcopy and compare this to pathology.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cervical cancer', 'cervical intraepithelial neoplasia grade 1', 'cervical intraepithelial neoplasia grade 2', 'cervical intraepithelial neoplasia grade 3'], 'conditions': ['Cervical Cancer', 'Precancerous Condition']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia.\n\nPURPOSE: This clinical trial is studying digital colposcopy to see how well it works in finding cervical intraepithelial neoplasia.', 'detailedDescription': 'OBJECTIVES:\n\n* To identify potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using digital colposcopy and fluorescence spectroscopic imaging.\n* To measure fluorescence and reflectance images of the human cervix in vivo using digital colposcopy.\n* To evaluate the effect of acetic acid on the image contrast obtained.\n* To compare the device performance with colposcopic impression and histopathologic interpretation of tissue removed by standard loop electrosurgical excision procedure (LEEP).\n\nOUTLINE: This is a multicenter study.\n\nParticipants undergo routine colposcopy as part of their regular colposcopic evaluation. The digital colposcope is used to take fluorescence and reflectance images of the vagina and cervix. Participants also undergo loop electrosurgical excision procedure (LEEP). The digital colposcopic images are compared with tissue removed during LEEP. Additional surrogate biomarkers under development are also measured using tissue samples removed during LEEP, such as quantitative histopathology measurements, DNA tests for the copy number changes, and tests for the incorporation of viral HPV DNA.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Criteria:\n\nInclusion criteria:\n\n* Included subjects will be ≥18 years old.\n* Included subjects will not be pregnant.\n* Included subjects will have a negative urine pregnancy test.\n* Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.\n* Included subjects will indicate understanding of the study.\n* Included subjects will provide informed consent to participate.\n\nExclusion criteria:\n\n* Individuals \\<18 years old will be excluded.\n* Pregnant individuals will be excluded.\n* Individuals that have had an operation to remove their cervix will be excluded.\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics"}, 'identificationModule': {'nctId': 'NCT00602368', 'briefTitle': 'Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'British Columbia Cancer Agency'}, 'officialTitle': 'Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study', 'orgStudyIdInfo': {'id': 'CDR0000581286'}, 'secondaryIdInfos': [{'id': 'BCCR-H03-61235', 'type': 'OTHER', 'domain': 'UBC-BCCA REB'}, {'id': 'P01CA082710', 'link': 'https://reporter.nih.gov/quickSearch/P01CA082710', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'histological technique', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'colposcopic biopsy', 'type': 'PROCEDURE'}, {'name': 'colposcopy', 'type': 'PROCEDURE'}, {'name': 'light-scattering spectroscopy', 'type': 'PROCEDURE'}, {'name': 'loop electrosurgical excision procedure', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1L3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Research Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Dianne M. Miller, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British Columbia Cancer Agency, Vancouver General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Columbia Cancer Agency', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}