Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-01 @ 1:41 PM
Study NCT ID:
NCT00511758
Status:
TERMINATED
Last Update Posted:
2012-08-01
First Post:
2007-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Imaging Aid for Assessment of Cervical Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'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': 'D000097913', 'term': 'Quantitative Phase Imaging'}], 'ancestors': [{'id': 'D008857', 'term': 'Microscopy, Interference'}, {'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Low accrual rate.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-31', 'studyFirstSubmitDate': '2007-08-02', 'studyFirstSubmitQcDate': '2007-08-03', 'lastUpdatePostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.', 'timeFrame': '2 Year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical Dysplasia', 'Digital Imaging', 'Colposcopy', 'Cervix'], 'conditions': ['Cervical Dysplasia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix.\n\nThe specific aims of the study are:\n\n* To compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue.\n* To develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix.\n* To analyze digital images to determine which types of optical information yield the most diagnostically useful data.', 'detailedDescription': 'If you agree to take part in this study, digital imaging will be performed for research purposes, after your routine colposcopy of your cervix.\n\nVISUAL DETECTION OF PRECANCEROUS LESIONS:\n\nReflectance (the ability of an area to reflect light) imaging helps doctors visually tell the difference between precancerous tissue, cancerous tissue, and normal tissue in the cervix. Researchers want find out whether a digital camera image can be as effective as colposcopy at screening for precancerous tissue.\n\nSTUDY PARTICIPATION:\n\nYou will be seen in the clinic during a routine visit. Your cervix will first be examined by the clinician using a standard white light headlamp, and the image will be recorded.\n\nYour cervix will then be re-examined with the digital camera, which will involve the use of different types of light (standard white light, green filtered light, cross and parallel polarized light). These digital images will be taken before and after acetic acid (vinegar) is applied.\n\nResearchers will use these images to make comparison studies with the colposcopy procedure.\n\nLENGTH OF STUDY:\n\nYour participation will be finished on this study once your cervix has been examined with the digital camera.\n\nThis is an investigational study. Up to patients 20 will take part in this study. All will be enrolled at M. D. Anderson.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years or older who are referred to the University of Texas MD Anderson Cancer Center Colposcopy Clinic for colposcopy are eligible for this study.\n* Patients must sign an informed consent indicating awareness of the investigational nature of this study.\n\nExclusion Criteria:\n\n* Patients who are pregnant are not eligible for this study.'}, 'identificationModule': {'nctId': 'NCT00511758', 'briefTitle': 'Digital Imaging Aid for Assessment of Cervical Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia', 'orgStudyIdInfo': {'id': '2007-0230'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Digital Imaging Device', 'description': 'Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.', 'interventionNames': ['Procedure: Digital Imaging']}], 'interventions': [{'name': 'Digital Imaging', 'type': 'PROCEDURE', 'description': 'Images of the cervix will be taken using different types of light and compared with the colposcopy procedure.', 'armGroupLabels': ['Digital Imaging Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'U.T.M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Michele Follen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}