Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-02-04 @ 4:03 PM
Study NCT ID:
NCT00977392
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2009-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014626', 'term': 'Vaginal Smears'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D003127', 'term': 'Colposcopy'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2009-09-12', 'studyFirstSubmitQcDate': '2009-09-12', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the percentages of women responding to the invitation to return a self-sampling kit vs responding to an invitation for a cervical smear'}], 'secondaryOutcomes': [{'measure': 'Response to the invitation for further investigation following a positive test result (colposcopy for women with a smear showing mild dyskaryosis or above, smear +/- colposcopy for those with a positive HPV test)'}, {'measure': 'Response to the request to return a survey regarding demographic information and reasons for previous non-attendance for screening'}]}, 'conditionsModule': {'keywords': ['human papilloma virus infection', 'health status unknown'], 'conditions': ['Health Status Unknown', 'Precancerous Condition']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/21343937', 'label': 'HPV self-sampling as an alternative strategy in non-attenders for cervical screening - a randomised controlled trial. Br J Cancer. 2011 Mar 15;104(6):915-20. doi: 10.1038/bjc.2011.48. Epub 2011 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Women who do not undergo routine cervical screening may be more likely to collect a self-sample for human papillomavirus testing.\n\nPURPOSE: This randomized clinical trial is studying self-sampling in women who do not undergo routine cervical screening.', 'detailedDescription': "OBJECTIVES:\n\n* To ascertain whether women who do not attend for cervical screening are more likely to respond to the opportunity to collect a self-sample for human papillomavirus (HPV) testing, or to respond to a further invitation to undergo a cervical smear.\n* To ascertain whether such women will attend for further investigation if they have a positive screening test (HPV test or cervical smear).\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\n* Control: Patients receive an invitation for a routine cervical smear and a cervical screening survey. Information regarding attendance for smear or colposcopy is collected at the Primary Care Trust.\n* Study (self-sampling kit): Patients receive an explanatory letter, an information sheet about the study, a consent form, information about human papillomavirus (HPV) and HPV testing, a self-sampling test kit, and an invitation to take their own HPV sample and return it to the research group for processing. Patients also receive a cervical screening survey. Patients who attend for further investigation following a positive HPV result go to St. Mary's Hospital Colposcopy Unit, Paddington. During this visit cervical smear tests are performed and women are offered immediate colposcopy so that they would not need to return for colposcopic examination if their smear test is abnormal.\n\nThis study is peer reviewed and funded or endorsed by cancer research UK."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Women in Westminster Primary Care Trust (PCT) area eligible for routine cervical screening who have not responded to two invitations to attend for smears\n* No women who have written to the PCT to document their refusal to take part in the National Health Service Cervical Screening Program (NHSCSP)\n* No women who are not due for routine screening as part of the NHSCSP\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant\n* Have been sexually active\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior total abdominal hysterectomy'}, 'identificationModule': {'nctId': 'NCT00977392', 'briefTitle': 'Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'CRUK-Westminster-Self-Sampling'}, 'secondaryIdInfos': [{'id': 'CDR0000648274', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'ISRCTN40182307', 'type': 'REGISTRY', 'domain': 'ISRCTN (International Standard Randomised Controlled Trial Number Register)'}, {'id': 'EU-20963'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'compliance monitoring', 'type': 'BEHAVIORAL'}, {'name': 'cervical Papanicolaou test', 'type': 'OTHER'}, {'name': 'educational intervention', 'type': 'OTHER'}, {'name': 'screening questionnaire administration', 'type': 'OTHER'}, {'name': 'survey administration', 'type': 'OTHER'}, {'name': 'colposcopy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW15 5PN', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Barts and the London School of Medicine', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Anne Szarewski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary University of London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts and the London School of Medicine and Dentistry', 'class': 'OTHER'}}}}