Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-26 @ 6:13 AM
Study NCT ID:
NCT04927650
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'HPV samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who complete screening', 'timeFrame': '1 day', 'description': 'The absolute number of participants successfully completing screening.'}, {'measure': 'Proportion of women 25-49 years of age who complete screening', 'timeFrame': '1 day', 'description': 'Overall proportions of women 25-49 years old successfully completing cervical cancer screening.'}, {'measure': 'Proportion of participants who receive treatment after a positive screening result', 'timeFrame': '6 months', 'description': 'Proportion of participants who receive treatment after screening positive for high-risk human papillomavirus (HPV) will be calculated with a 95% confidence interval.'}, {'measure': 'Proportion of participants with positive, high-risk human papillomavirus (HPV)', 'timeFrame': '1 day', 'description': 'Prevalence of participants with positive high-risk human papillomavirus (HPV)'}, {'measure': 'Proportion of participants with cervical intraepithelial neoplasia (CIN2)+', 'timeFrame': '1 day', 'description': 'Proportion of participants with cervical intraepithelial neoplasia (CIN2)+'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical Cancer Screening', 'Human Papillomavirus', 'HPV'], 'conditions': ['Cervical Carcinoma', 'Human Papillomavirus-Related Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study examines prevention and early detection of cervical cancer through self-administration screening of patients in Western Uganda. The cervix is the opening of the uterus or womb, which is the organ that supports babies before they are born. There are simple tests that let doctors know whether or not patients have cells that may become cancer. Some of the tests determine whether patients have an increased risk for cervical disease, but they do not actually confirm that they have it: these are called "screening" tests. This study may help researchers determine how to best deliver cervical cancer prevention services using the HPV test.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To establish the acceptance and correlates of self-collected human papillomavirus (HPV)-ribonucleic acid (RNA) testing among women in the rural Ugandan community as well as the incidence and determinants of successful completion of the cervical cancer screening cascade from self-collected HPV testing to receipt of results.\n\nII. To ascertain the frequency and determinants of successful acquisition of treatment among women who have HPV detected on self-collected swabs in rural Uganda.\n\nIII. To derive population-based estimates of the prevalence of high-risk HPV and cervical intraepithelial neoplasia (CIN) detected through community-based screening employing self-collected HPV RNA testing in rural Uganda.\n\nOUTLINE:\n\nPatients receive a specimen kit for collection of HPV samples. Patients complete questionnaire before and after collection HPV samples. Patients may also participate in an interview about general ideas in improving the screening and treatment process. Patients with positive results, undergo treatment for cervical cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women in the three Ugandan districts (Kiboga, Kyankwanzi and Hoima) who access screening during the community health campaigns', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women in the three Ugandan districts (Kiboga, Kyankwanzi and Hoima) who access screening during the community health campaigns\n* Age 25-49 years\n* Resident in the study district\n* Provision of informed consent\n\nExclusion Criteria:\n\n* Clinical signs and symptoms of cancer of the cervix'}, 'identificationModule': {'nctId': 'NCT04927650', 'briefTitle': 'Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening in the Community', 'orgStudyIdInfo': {'id': '18405'}, 'secondaryIdInfos': [{'id': 'NCI-2021-02021', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'U54CA190153', 'link': 'https://reporter.nih.gov/quickSearch/U54CA190153', 'type': 'NIH'}, {'id': 'U54CA254571', 'link': 'https://reporter.nih.gov/quickSearch/U54CA254571', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Screening', 'description': 'Patients receive a specimen kit for collection of HPV samples. Patients complete questionnaire before and after collection HPV samples. Patients may also participate in an interview about general ideas in improving the screening and treatment process. Patients with positive results, undergo treatment for cervical cancer.', 'interventionNames': ['Diagnostic Test: HPV testing', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'HPV testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Undergo collection of cervical samples for HPV testing', 'armGroupLabels': ['Screening']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Screening']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Miriam Nakalembe', 'role': 'CONTACT', 'email': 'ivuds@yahoo.com', 'phone': '0753-857433'}, {'name': 'Miriam Nakalembe, MBChB, MMed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Makerere University College of Health Sciences School of Medicine', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'centralContacts': [{'name': 'Jeffrey Martin, MD, MPH', 'role': 'CONTACT', 'email': 'Jeffrey.Martin@ucsf.edu', 'phone': '(415) 514-8010'}], 'overallOfficials': [{'name': 'Jeffrey Martin, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}