Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 11:02 AM
Study NCT ID:
NCT06669533
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2024-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use Misoprostol to Optimize Prevention of Cervical Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The PIs, nurses who will be providing the drugs, and study participants will be blinded in the study.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-11-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conversion rate from Type 3 transformation zone (TZ) to Types 1 or 2', 'timeFrame': 'Approximately 2-3 hours and approximately 4-6 hours since drug administration', 'description': 'The rate of participants with successful transformation from Type 3 (TZ) to Type 1 or 2 (TZ) will be calculated. It is the number of participants who successfully transformed from Type 3 TZ to Type 1 or 2 TZ, divided by the total number of participants in the entire randomized cohort.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the rate of patients converted from Type 3 TZ to Type 1 or 2 TZ between 2-3 hours and 4-6 hours', 'timeFrame': 'Approximately 2-3 hours vs approximately 4-6 hours', 'description': 'The rate of transformation from Type 3 transformation zone (TZ) to Type 1 or 2 TZ between 2-3 hours and 4-6 hours after administering misoprostol will be compared. The rate is calculated as the number of successful transformations within each time period (2-3 hours or 4-6 hours) divided by the total cohort.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical cancers'], 'conditions': ['Cervical Cancers']}, 'descriptionModule': {'briefSummary': 'This is a double-blind randomized controlled trial of 420 non-pregnant women undergoing cancer screening by visual inspection with acetic acid (VIA) who have Type 3 transformation zone (TZ) and randomized to receive either Misoprostol or placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Non-pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Type 3 TZ confirmed on exam prior to randomization\n* Age 25 years or older\n\nExclusion Criteria:\n\n* With Type 1 or 2 TZ prior to randomization\n* Currently pregnant\n* History of hysterectomy\n* Any cancerous lesions\n* Active cervicitis'}, 'identificationModule': {'nctId': 'NCT06669533', 'acronym': 'MISOPCx', 'briefTitle': 'Use Misoprostol to Optimize Prevention of Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Misoprostol to Optimizing Prevention of Cancer of the Cervix: A Double-Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB-30012879'}, 'secondaryIdInfos': [{'id': '1R01CA279021', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA279021', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-pregnant women', 'description': 'Non-pregnant women will either receive 600 mcg misoprostol (3 tablets) or identical placebo 3 (tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).', 'interventionNames': ['Drug: Placebo', 'Drug: Misoprostol']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).', 'armGroupLabels': ['Non-pregnant women']}, {'name': 'Misoprostol', 'type': 'DRUG', 'description': 'Participants will receive 600 mcg misoprostol (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).', 'armGroupLabels': ['Non-pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2034', 'city': 'Yaoundé', 'state': 'Center Region', 'status': 'RECRUITING', 'country': 'Cameroon', 'contacts': [{'name': 'Simon M Manga, PhD', 'role': 'CONTACT', 'email': 'smanga@uab.edu', 'phone': '2059345612'}, {'name': 'Warner K Huh, MD', 'role': 'CONTACT', 'email': 'whuh@uabmc.edu', 'phone': '2059341555'}, {'name': 'Warner K Huh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Simon M Manga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cameroon Baptist Convention Health Core, EtougEbe Baptist Hospital Yaoundé', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}], 'centralContacts': [{'name': 'Warner K Huh, MD', 'role': 'CONTACT', 'email': 'whuh@uabmc.edu', 'phone': '2059341555'}, {'name': 'Simon M Manga, PhD', 'role': 'CONTACT', 'email': 'smanga@uab.edu', 'phone': '2059345612'}], 'overallOfficials': [{'name': 'Warner K Huh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cameroon Baptist Convention Health Core', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Warner Huh', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}