Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-30 @ 5:33 AM
Study NCT ID:
NCT06452004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2023-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'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'}, {'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': 'D011230', 'term': 'Precancerous Conditions'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In Uganda, India and Bangladesh eligible women in geographic areas are invited to perform self-test for hrHPV. hrHPV-positive women are invited for further examination of the cervix using VIA. In all VIAs pictures are taken with the device and the AI decision support system is activated. Health workers will give an independent VIA assessment before the AI assessment can be accessed. An expert panel gives an independent assessment without knowing the health worker or AI assessment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'User-friendliness of AI-DSS device among healthcare providers', 'timeFrame': 'through study completion, estimated 2 years', 'description': 'Scoring on Likert scale by healthcare providers using AI-DSS device based on their assessment of device software human machine interface, weight, size, flashlight,'}], 'primaryOutcomes': [{'measure': 'Accuracy, sensitivity, specificity of AI-DSS', 'timeFrame': 'through study completion, estimated 2 years', 'description': 'Measurement of true and false positive and true and false negative results of the AI DSS in relation to assessment by expert panel'}], 'secondaryOutcomes': [{'measure': 'Percentage of quality pictures', 'timeFrame': 'through study completion, estimated 2 years', 'description': 'Percentage of pictures taken during the VIA procedures, which meet according to the expert panel the quality standards suitable for AI-DSS assessment, based on visibility of cervix and Squamo-Columnar Junction (SCJ), light, reflection of speculum, mucus-free surface'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Visual Inspection cervix', 'Artificial Intelligence', 'Screening Cervical Cancer', 'decision support system'], 'conditions': ['HPV Infection', 'Cervix Cancer', 'Cervical Dysplasia']}, 'referencesModule': {'references': [{'pmid': '35840949', 'type': 'BACKGROUND', 'citation': 'Sultanov M, Zeeuw J, Koot J, der Schans JV, Beltman JJ, Fouw M, Majdan M, Rusnak M, Nazrul N, Rahman A, Nakisige C, Rao AP, Prasad K, Guruvare S, Biesma R, Versluis M, de Bock GH, Stekelenburg J. Investigating feasibility of 2021 WHO protocol for cervical cancer screening in underscreened populations: PREvention and SCReening Innovation Project Toward Elimination of Cervical Cancer (PRESCRIP-TEC). BMC Public Health. 2022 Jul 15;22(1):1356. doi: 10.1186/s12889-022-13488-z.'}, {'pmid': '37666527', 'type': 'BACKGROUND', 'citation': 'Nakisige C, de Fouw M, Kabukye J, Sultanov M, Nazrui N, Rahman A, de Zeeuw J, Koot J, Rao AP, Prasad K, Shyamala G, Siddharta P, Stekelenburg J, Beltman JJ. Artificial intelligence and visual inspection in cervical cancer screening. Int J Gynecol Cancer. 2023 Oct 2;33(10):1515-1521. doi: 10.1136/ijgc-2023-004397.'}]}, 'descriptionModule': {'briefSummary': 'The research project is a component of another research project that applies the protocol of the World Health Organization for screening of cervical cancer, with testing of high-risk Human Papilloma Virus (hrHPV) as first screening. In the screen, triage and treat approach women who tested positive for hrHPV are undergoing Visual Inspection of the cervix with Acetic Acid (VIA). This procedure is applied in Uganda, India and Bangladesh. However the quality of VIA by lower-trained staff is variable because Low and Middle Income Countries face limited numbers of qualified health care professionals. Artificial intelligence (AI) might be a solution to improve consistency of VIA assessment. This research validates an AI decision support system (AI-DSS) under field conditions.', 'detailedDescription': 'This research project aims to validate an image processing algorithm in order to study if the AI can function as decision support system (DSS) for healthcare workers, who perform VIA. The AI-DSS has been designed by the Manipal Academy of Higher Education in India and has shown a sensitivity of 99.05% and specificity of 97.16% for detection of aceto-white lesions.\n\nThe first step of the validation process is a dry run using a database of VIA pictures with pathology confirmation. The accuracy, sensitivity and specificity of healthcare workers, an expert team and the AI will be analysed, based on the ground truth of database pictures.\n\nThereafter, the AI-DSS will be validated under field conditions. Women who are hrHPV-positive in Uganda, India and Bangladesh will undergo a VIA. The AI is incorporated in a device, that can take pictures of the cervix and provide and instant report (positive = needs further investigation or negative = no lesions found). The user experience of the device will be evaluated.\n\nThe AI-DSS will be validated by comparing the VIA assessment by health workers, the AI with assessment by the expert panel. Accuracy, sensitivity and specificity of the AI algorithm will be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female in eligible age group\n* Women who tested HPV positive and are eligible for VIA\n* Ability to give informed consent and participate in study\n\nExclusion Criteria:\n\n* Clinical signs of cervical carcinoma\n* Menstruation or other vaginal blood loss\n* HPV negative women'}, 'identificationModule': {'nctId': 'NCT06452004', 'acronym': 'AI-DSS', 'briefTitle': 'Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer: Validation of Artificial Intelligence as Decision Support System in VIA', 'orgStudyIdInfo': {'id': '2022300195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI-DSS validation Bangladesh', 'description': 'Women in selected intervention area in Bangladesh, who tested hrHPV-positive eligible for VIA, are included. VIA is performed. During VIA the health worker performs an assessment. With the device a picture and taken and AI-DSS generates and assessment as well. The pictures are also assessed by an expert panel.', 'interventionNames': ['Diagnostic Test: Validation of AI-DSS in Bangladesh']}, {'type': 'EXPERIMENTAL', 'label': 'AI-DSS validation Uganda', 'description': 'Women in selected intervention area in Uganda, who tested hrHPV-positive eligible for VIA, are included. VIA is performed. During VIA the health worker performs an assessment. With the device a picture and taken and AI-DSS generates and assessment as well. The pictures are also assessed by an expert panel.', 'interventionNames': ['Diagnostic Test: Validation of AI-DSS in Uganda']}, {'type': 'EXPERIMENTAL', 'label': 'AI-DSS validation India', 'description': 'Women in selected intervention area in India, who tested hrHPV-positive eligible for VIA, are included. VIA is performed. During VIA the health worker performs an assessment. With the device a picture and taken and AI-DSS generates and assessment as well. The pictures are also assessed by an expert panel.', 'interventionNames': ['Diagnostic Test: Validation of AI-DSS in India']}], 'interventions': [{'name': 'Validation of AI-DSS in Bangladesh', 'type': 'DIAGNOSTIC_TEST', 'description': 'VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.', 'armGroupLabels': ['AI-DSS validation Bangladesh']}, {'name': 'Validation of AI-DSS in Uganda', 'type': 'DIAGNOSTIC_TEST', 'description': 'VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.', 'armGroupLabels': ['AI-DSS validation Uganda']}, {'name': 'Validation of AI-DSS in India', 'type': 'DIAGNOSTIC_TEST', 'description': 'VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.', 'armGroupLabels': ['AI-DSS validation India']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kakumiro', 'country': 'Uganda', 'facility': 'Mpasana', 'geoPoint': {'lat': 0.78056, 'lon': 31.32361}}], 'overallOfficials': [{'name': 'Jelle Stekelenburg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}, {'name': 'Janine de Zeeuw, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}, {'name': 'Jogchum Beltman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Female Cancer Foundation'}, {'name': 'Keerthana Prasad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manipal Academy for Higher Education'}, {'name': 'Carol Nakisige, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uganda Cancer Institute'}, {'name': 'Aminur Rahman Shaheen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh'}]}, 'ipdSharingStatementModule': {'url': 'http://www.prescriptec.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After 1 January 2024', 'ipdSharing': 'YES', 'description': 'Sharing according to the European Union Open Research guidelines', 'accessCriteria': 'As per Open Research Protocol, on request to Principal Investigator UMCG'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uganda Cancer Institute', 'class': 'OTHER'}, {'name': 'Female Cancer Foundation', 'class': 'UNKNOWN'}, {'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}, {'name': 'Manipal Academy for Higher Education', 'class': 'UNKNOWN'}, {'name': 'Friendship Bangladesh', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}