[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467877":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":99,"collaborators":101,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":13,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":13,"studyType":119,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":47,"whyStopped":13,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Development of multimodal optical imaging system","Image data will be used as a training set to develop and refine image analysis algorithms. Multimodal Mobile Colposcope will be compared with colposcopic impression considering clinical performance (sensitivity, specificity, positive and negative predictive values, and area under the Receiver Operating Characteristic (ROC) curve)","through study completion, an average of 1 year",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","SCREENING",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","This is a prospective, single-arm community trial involving 678 women aged 25 to 49 years for evaluation of positive cervical cancer screening tests (abnormal cytology, VIA+ and\u002For HPV+ test). Eligible women will be offered enrollment at the time of their consultation for a follow-up of their abnormal cervical cancer screening test.\n\nParticipating centers include: 1) Mavalane Hospital and Health Center and 2) José Macamo General Hospital (José Macamo), 3) Maputo Central Hospital. After providing the informed consent, the participant will answer a short questionnaire that will include demographic information and medical background, including HIV status (HIV-negative, positive, or unknown, and, among women with HIV-positive tests, HIV viral load and CD4 cell count, if available), and cervical cancer screening test results.\n\nThe patient will undergo a rapid urine - POC pregnancy test (within 14 days from the date of enrollment). Each participant will then receive instructions and will provide two cervico-vaginal samples taken by the patient herself (self-collection).\n\nThe patient will then undergo a pelvic examination with two cervical samples taken by the healthcare provider. 7. A sample taken by the patient herself (self-collection) and a sample taken by the provider will be sent for an HPV test using GeneXpert. Similarly, samples taken by the patient herself (self-collection) and collected by the provider will be stored for the Rice POC rapid HPV test.\n\nThe patient will then undergo multimodal imaging. Images\u002Fvideos of the cervix will be obtained using the mobile colposcope\u002Fsmartphone and HRME images\u002Fvideos will be also obtained.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"Multi-Modal Optical Imaging","EXPERIMENTAL","Multi-modal imaging (mobile colposcopy and high resolution imaging) of study participants will be performed during the colposcopy examination. Cervical biopsies will be performed using biopsy forceps per standard protocols.",[27],"Device: Multimodal optical imaging",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"DEVICE","Multimodal optical imaging","Women referred for colposcopy due to abnormal cervical screening will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.",[23],[35],{"name":36,"affiliation":5,"role":37},"Kathleen Schmeler, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},"Mila Salcedo, MD, PhD","CONTACT","(832) 696-6794","mpsalcedo@mdanderson.org",[45,64,80,89],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-95.36327,29.76328,{"lat":57,"lon":56},[60,63],{"name":36,"role":41,"phone":61,"phoneExt":13,"email":62},"713-854-9150","kschmele@mdanderson.org",{"name":36,"role":37,"phone":13,"phoneExt":13,"email":13},{"facility":65,"status":47,"city":66,"state":13,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"José Macamo General Hospital and Health Center","Maputo","1106","Mozambique","MZ",{"type":54,"coordinates":71},[72,73],32.58322,-25.96553,{"lat":73,"lon":72},[76,78],{"name":77,"role":41,"phone":13,"phoneExt":13,"email":13},"Andrea Neves",{"name":79,"role":37,"phone":13,"phoneExt":13,"email":13},"Cesaltina Lorenzoni, MD, PhD",{"facility":81,"status":47,"city":66,"state":13,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Maputo Central Hospital",{"type":54,"coordinates":83},[72,73],{"lat":73,"lon":72},[86,88],{"name":87,"role":41,"phone":13,"phoneExt":13,"email":13},"Ricardina Rangeiro",{"name":79,"role":37,"phone":13,"phoneExt":13,"email":13},{"facility":90,"status":47,"city":66,"state":13,"zip":91,"country":68,"countryCode":69,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"Mavalane Hospital and Health Center","1108",{"type":54,"coordinates":93},[72,73],{"lat":73,"lon":72},[96,98],{"name":97,"role":41,"phone":13,"phoneExt":13,"email":13},"Arlete Mariano",{"name":79,"role":37,"phone":13,"phoneExt":13,"email":13},{"type":100,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[102,104],{"name":103,"class":6},"Eduardo Mondlane University",{"name":105,"class":6},"William Marsh Rice University","100467877","rice-technologies-for-cervical-cancer-screening-and-diagnosis-100467877",false,"NCT05372484","Rice Technologies for Cervical Cancer Screening and Diagnosis","Assessment of New Technologies for the Screening and Diagnosis of Cervical Cancer in Mozambique, A Study to be Conducted in Maputo Central Hospital, Mavalane and Jose Macamo General Hospitals and Mavalane Health Center","Inclusion Criteria:\n\n1. 25 - 49 year old women\n2. Women with a positive cervical cancer screening test (abnormal cytology, positive VIA and\u002For positive HPV test)\n3. Women with intact cervix\n4. Women who are not pregnant and with a negative pregnancy test (within 14 days from the date of enrollment) ) and not currently breastfeeding\n5. Willing and capable of providing informed consent\n\nExclusion Criteria:\n\n1. Women under 25 or over 49 years old\n2. Women who have undergone a total hysterectomy (with removal of the cervix)\n3. Women who are pregnant or breastfeeding","FEMALE","25 Years","49 Years",{"count":117,"type":118},678,"ESTIMATED","INTERVENTIONAL",[15],"The study aims to compare the accuracy of the lateral flow test to detect HPV at the POC with commercially available HPV test and to determine the diagnostic accuracy and reliability of a multimodal optical imaging system to detect cervical dysplasia, with the gold reference standard of histopathology.",[123],"Cervical Cancer",[125,126,127,128],"Human Papilloma virus","Point-of-care HPV Test","Multimodal Optical Imaging","Screening","2026-08-07",{"date":131,"type":132},"2026-08-10","ACTUAL",{"date":134,"type":132},"2021-03-24",{"date":136,"type":118},"2028-03-30",{"name":5,"class":6},4]