Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:28 AM
Study NCT ID:
NCT07468695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS2 Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Clinical Site staff involved in provision of clinical care, recruitment, or follow-up will be blinded to allocation until after visual inspection.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with persistent HPV at 6 months', 'timeFrame': 'From enrollment to follow up at 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Cervical cancer screening', 'Treatment of Cervical Precancer', 'Thermal ablation', 'Human papillomavirus'], 'conditions': ['HIV (Human Immunodeficiency Virus)', 'HPV', 'Cervical Precancer']}, 'descriptionModule': {'briefSummary': 'Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. In Kenya, the estimated incidence rate of cervical cancer is 31-33 per 100,000 women per year among women without HIV and approximately 70-100 per 100,000 among WLWH.\n\nThe proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030.', 'detailedDescription': 'Participants will first undergo HPV testing or visual inspection with acetic acid at screening. Participants with positive screening results undergo a clinical exam comprising visual inspection with acetic acid, digital imaging, brush biopsies of the ectocervix and the endocervix, and assessment for TA treatment. Participants who have a type 1 transformation zone (TZ1) and are otherwise eligible for TA will receive TA with either one or two probes. Screen positive women will be randomized to:\n\nGROUP 1: TA with 1 probe. GROUP 2: TA with 2 probes.\n\nParticipants are followed up at 6 months with an HPV test, brush biopsies, and visual assessment of the cervix.\n\nParticipants who are not TA eligible will be referred to local care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 25-49 years old\n2. Living with HIV\n\nInclusion criteria specific to the feasibility study\n\n1. Intact cervix\n2. Willing to return to facility at 6 months\n3. Willing and able to provide informed consent\n4. Positive hrHPV or VIA test within 3 months of enrollment\n5. Type 1 transformation zone (TZ1)\n6. Thermal ablation eligible\n\nExclusion Criteria:\n\n1. Screened for cervical cancer outside of study in last 6 months\n2. Currently pregnant or less than 6 weeks postpartum\n3. Prior diagnosis of cervical cancer\n4. A history of treatment for cervical precancer\n5. Total hysterectomy\n6. Currently receiving treatment for any cancer\n7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study\n8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled'}, 'identificationModule': {'nctId': 'NCT07468695', 'briefTitle': 'Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS2 Kenya', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV', 'orgStudyIdInfo': {'id': 'RG1124082 (C1001P-CS2 Kenya)'}, 'secondaryIdInfos': [{'id': 'UG1CA275402', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA275402', 'type': 'NIH'}, {'id': 'U24CA275417', 'link': 'https://reporter.nih.gov/quickSearch/U24CA275417', 'type': 'NIH'}, {'id': 'UG1CA275400', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA275400', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (TA with 1 probe)', 'description': 'Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo TA with 1 probe at month 0.', 'interventionNames': ['Procedure: Thermal ablation (TA) with 1 probe']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (TA with 2 probes)', 'description': 'Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo TA with 2 probes at month 0.', 'interventionNames': ['Procedure: Thermal ablation (TA) with 2 probes']}], 'interventions': [{'name': 'Thermal ablation (TA) with 1 probe', 'type': 'PROCEDURE', 'description': 'Undergo TA with 1 probe', 'armGroupLabels': ['Group 1 (TA with 1 probe)']}, {'name': 'Thermal ablation (TA) with 2 probes', 'type': 'PROCEDURE', 'description': 'Undergo TA with 2 probes', 'armGroupLabels': ['Group 2 (TA with 2 probes)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nairobi', 'country': 'Kenya', 'contacts': [{'name': 'Samah Rafie Sakr, MBChB, MRCS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael H Chung, MD, PhD, MPH, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Coptic Hope Center', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}], 'centralContacts': [{'name': 'Araceli Loera, MPH', 'role': 'CONTACT', 'email': 'aloera@fredhutch.org', 'phone': '+1 206-667-5816'}, {'name': 'Mark A Mounir', 'role': 'CONTACT', 'email': 'mmounir@coptichospitals.org', 'phone': '+254 768027841'}], 'overallOfficials': [{'name': 'Rachel L Winer, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Margaret M Madeleine, PhD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Fred Hutchinson Cancer Center'}, {'name': 'Leeya Pinder, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Deidentified data, the study protocol, and the data dictionary will be made available to qualified investigators within 6 months of acceptance of the manuscript describing major outcomes, for up to 5 years.', 'ipdSharing': 'YES', 'description': 'Research data will be shared in a timely manner, with appropriate privacy and confidentiality protections, using the policies and procedures outlined in the NIH Guidelines for Sharing Research Data. Guidelines, oversight, and requirements for sharing data are based on the institutional policies, IRB rules, and local, state, and federal laws and regulations. In all cases, the privacy and confidentiality of all people who participate in the research will be protected. Clinical data on women living with HIV generated during the study will be made available to researchers in both the private and public sector free or for a nominal charge.', 'accessCriteria': 'Requestors will be required to obtain IRB approval and sign a data use agreement before data will be released. The data use agreement must include the following commitments: a commitment to using the data for research purposes only and not to identify any individual participants; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; and a commitment to meet any additional requirements that might be stipulated by the Kenyatta-National Hospital-University of Nairobi (KNH-UON).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'University of Cincinnati', 'class': 'OTHER'}, {'name': 'Frontier Science & Technology Research Foundation, Inc.', 'class': 'INDUSTRY'}, {'name': 'Emory University', 'class': 'OTHER'}, {'name': 'Coptic Hope Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Margaret M. Madeleine, PhD', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}