Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-30 @ 4:29 PM
Study NCT ID:
NCT06898203
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Imaging to Evaluate Kaposi Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012514', 'term': 'Sarcoma, Kaposi'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only', 'timeFrame': 'Approximately 3 months', 'description': 'Reproducibility/agreement between clinicians for each method is measured using the concordance correlation coefficient (CCC). A higher CCC means a more reproducible method.'}, {'measure': 'Accuracy of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only', 'timeFrame': 'Approximately 3 months', 'description': 'Accuracy is measured using the coefficient of determination (R-squared). The R-squared tells us how much variation is due to varying lesion size as measured by either method versus how much variation is due to random error. When the variation due to random error is small, the R-squared value is closer to 1; when the variation due to random error is large, the R-squared value is farther from 1.'}, {'measure': 'Device usability - Aim 3 Only', 'timeFrame': '6 months', 'description': 'Device usability will be measured using the System Usability Scale. The SUS will result in a single composite score for each individual and the scores will be averaged to result in a single overall usability score.'}, {'measure': 'Acceptability - Aim 3 Only', 'timeFrame': '6 months', 'description': "Acceptability of Intervention Measure (AIM), present participants with a set of 4 questions regarding their perception of an intervention's acceptability, typically on a 5-point Likert scale (completely disagree to completely agree), then calculate the average score across all items, with higher scores indicating greater perceived acceptability of the intervention."}, {'measure': 'Appropriateness - Aim 3 Only', 'timeFrame': '6 months', 'description': 'Intervention Appropriateness Measure (IAM), will present a set of four questions to healthcare providers about how well SS3D works in their context. Each item is rated on a Likert scale, with higher scores indicating greater perceived appropriateness.'}, {'measure': 'Feasibility - Aim 3 Only', 'timeFrame': '6 months', 'description': 'FIM (Feasibility of Intervention Measure), will give the four-item questionnaire to healthcare providers asking them to rate how feasible they believe a specific intervention is on a Likert scale, usually ranging from "completely disagree" to "completely agree"; a higher score indicates greater perceived feasibility, with the average score across all items representing the overall feasibility rating of the intervention in that context.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Global Oncology', 'Kaposi Sarcoma', 'Affordable Cancer Technologies', 'Cancer in People with HIV', 'Human Centered Design', 'Discrete Choice Experiment', 'Medical devices', 'Low-cost design', 'Global health'], 'conditions': ['Kaposi Sarcoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}, {'url': 'https://www.kemri.go.ke/', 'label': 'Related Info'}, {'url': 'https://idi.mak.ac.ug/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'AIM 1:\n\nIn Uganda and Kenya, Kaposi Sarcoma (KS) is one of the most common cancers and a leading cause of cancer-related deaths in men. However, tracking how well patients are responding to treatment is challenging, especially in busy clinics. Doctors must measure the size and changes in the areas affected by the cancer by hand, which can take a lot of time and can vary depending on the doctor. This method does not work well for patients with dark skin, which can lead to biases in treatment compared to patients with fairer skin.\n\nTo solve this problem, the investigators suggest the use of a simple, low-cost device that uses Artificial Intelligence (AI), the SkinScan3D (SS3D) device, to measure the cancer spots accurately and monitor changes over time. The goal of this study is to improve the SkinScan3D (SS3D) tool and the how it is used. The investigators will do this by talking to healthcare workers and patients, giving them surveys, and holding design workshops. The feedback from these activities will be shared with the device maker and local research teams to make the device better and ensure it is used properly.\n\nAIMS 2 \\& 3:\n\nIn this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria - Aim 2 (Patients):\n\n* Adults age ≥18 years old\n* Histopathology-confirmed Kaposi Sarcoma\n* At least 3 skin lesions\n* Capable of informed consent\n* On treatment for Kaposi Sarcoma\n\nExclusion Criteria - Aim 2 (Patients):\n\n* Patients not initiating Kaposi Sarcoma treatment\n* Very ill patients requiring hospitalization\n\nInclusion Criteria - Aim 3 (Patients):\n\n* Adults age ≥18 years old\n* Histopathology-confirmed Kaposi Sarcoma\n* Capable of informed consent\n* Initiating treatment for Kaposi Sarcoma\n\nExclusion Criteria - Aim 3 (Patients):\n\n* Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2\n* Prior or ongoing Kaposi Sarcoma treatment'}, 'identificationModule': {'nctId': 'NCT06898203', 'acronym': 'PRIME-KS', 'briefTitle': 'Precision Imaging to Evaluate Kaposi Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS)', 'orgStudyIdInfo': {'id': '202411179'}, 'secondaryIdInfos': [{'id': 'U01CA292765', 'link': 'https://reporter.nih.gov/quickSearch/U01CA292765', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Aim 2: Patients', 'description': 'Patients will have three discrete skin lesions measured, with lesion area determined by ACTG criteria utilizing the product of longest perpendicular diameters. Patients will also have five 3D snapshots of each of the three target lesions taken, measuring lesion area automatically using SS3D.', 'interventionNames': ['Device: SkinScan3D']}, {'type': 'OTHER', 'label': 'Aim 3: Patients', 'description': 'Providers will first measure KS lesions using the manual ruler-based method as per usual standard of care for the first three months. After the first three months, providers will switch to using SkinScan3D for KS skin lesion measurement.', 'interventionNames': ['Device: SkinScan3D']}], 'interventions': [{'name': 'SkinScan3D', 'type': 'DEVICE', 'otherNames': ['SS3D'], 'description': 'A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).', 'armGroupLabels': ['Aim 2: Patients', 'Aim 3: Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Elizabeth Bukusi, MBChB, MMED, MPH, PhD', 'role': 'CONTACT', 'email': 'ebukusi@kemri.go.ke', 'phone': '+254 0722 205 901'}, {'name': 'Elizabeth Bukusi, MBChB, MMED, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Victor Mudhune, Bpharm', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kenya Medical Research Institute', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Aggrey Semeere, MBChB, MMed, MAS, FCP (ECSA)', 'role': 'CONTACT', 'email': 'aseeere@idi.co.ug', 'phone': '+256 772 621181'}, {'name': 'Aggrey Semeere, MBChB, MMed, MAS, FCP (ECSA)', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fred Okuku, MBChB, MMed', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Infectious Diseases Institute, Makerere University', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'centralContacts': [{'name': 'Thomas Odeny, MBChB, MPH, PhD', 'role': 'CONTACT', 'email': 'odeny@wustl.edu', 'phone': '314-273-3022'}], 'overallOfficials': [{'name': 'Thomas Odeny, MBChB, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'All data associated with study will be made available at the time of the first publication associated with the data. We anticipate that this will occur approximately 12 months following the completion of field work and within the award period. Study data deposited in WURD and QDR will be available to the public in perpetuity. Datasets related to methodological publications will be shared at publication.', 'ipdSharing': 'YES', 'description': 'All participants will consent to the sharing of aggregate de-identified quantitative and qualitative data. Any potentially identifying variables will be stripped from the public-use data in compliance with Washington University IRB policies and human subject protections. Participants will have the option to consent to sharing their identifiable survey data for future research and scholarly use as part of a data donation agreement. These identifiable data will be made available as a separate, identifiable dataset in WURD. All deidentified study data that are not designated as restricted use will be made available as public use data to the research community via the WURD or QDR. Data that are determined to be potentially identifying though indirect or deductive disclosure are provided under restricted data contract to users who have a valid research need and meet conditions of use.', 'accessCriteria': 'Contact Dr. Thomas Odeny'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Pensievision', 'class': 'UNKNOWN'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}, {'name': 'Makerere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}