[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648304":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":43,"locations":54,"responsibleParty":72,"collaborators":48,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":48,"enrollmentInfo":84,"targetDuration":48,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":56,"whyStopped":48,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Masaryk Memorial Cancer Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"p16 positive OPC patients","EXPERIMENTAL","20 patients with OPC who were indicated for standard radiation therapy or concomitant chemoradiation therapy and who were p16-positive.",[13,14],"Diagnostic Test: HPV p16","Diagnostic Test: HPV testing - positive results",{"label":16,"type":17,"description":18,"interventionNames":19},"p16 negative OPC patients","ACTIVE_COMPARATOR","The negative controls will be patients with OPC who are indicated for radiotherapy alone or concomitant chemoradiotherapy and who are p16-negative (approximately 10-15).",[13,20],"Diagnostic Test: HPV testing - negative results",[22,31,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIAGNOSTIC_TEST","HPV p16","Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients. We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity. By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.",[16,9],[28,29,30],"oral swabs","oral cavity washings","peripheral blood samples",{"type":23,"name":32,"description":25,"armGroupLabels":33,"otherNames":34},"HPV testing - positive results",[9],[28,29,30],{"type":23,"name":36,"description":25,"armGroupLabels":37,"otherNames":38},"HPV testing - negative results",[16],[28,29,30],[40],{"name":41,"affiliation":5,"role":42},"Tomáš Novotný, MUDr.","PRINCIPAL_INVESTIGATOR",[44,50],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"Martina Lojová, PhD","CONTACT","+420543136232",null,"martina.lojova@mou.cz",{"name":51,"role":46,"phone":52,"phoneExt":48,"email":53},"Martin Bartošík, PhD","+420543133306","martin.bartosik@mou.cz",[55],{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":48,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Brno","Czech Republic","65653","Czechia",{"type":62,"coordinates":63},"Point",[64,65],16.60796,49.19522,{"lat":65,"lon":64},[68,69,71],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},{"name":70,"role":46,"phone":52,"phoneExt":48,"email":53},"Martin Martošík, PhD",{"name":41,"role":42,"phone":48,"phoneExt":48,"email":48},{"type":73,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100648304","hpv-associated-oropharyngeal-carcinoma-hpv-opc-100648304",false,"NCT07718620","HPV-associated Oropharyngeal Carcinoma (HPV-OPC)","Validation of a New Method for Monitoring HPV Infection in Patients With Head and Neck Cancers","HPV-OPC","Inclusion Criteria:\n\n* a patient with an oropharyngeal tumor indicated for curative radiation therapy or chemoradiotherapy\n* if radiation therapy or chemoradiotherapy was preceded by surgery, the patient may be enrolled if the lesion persists on imaging studies\n* the lesion must be a histologically confirmed squamous cell carcinoma with known p16 status\n* age ≥ 18 years\n* the subject must be willing and able to provide written informed consent for specimen collection\n* ability to communicate effectively with the investigator in the local language, and ability to understand and comply with the study requirements\n\nExclusion Criteria:\n\n* previous induction chemotherapy\n* unknown p16 status, incomplete or inadequate histology-e.g., adenocarcinoma, melanoma, lymphoma,\n* previous radiation therapy to the oropharynx\n* palliative patients indicated for accelerated radiation therapy with a treatment duration of \\\u003C 5.5 weeks\n* age \\\u003C 18 years\n* pregnant or breastfeeding women\n* patients in the terminal stage of life\n* severe alcohol and\u002For drug abuse during treatment","ALL","18 Years",{"count":85,"type":86},35,"ESTIMATED","INTERVENTIONAL",[89],"NA","This study focuses on the longitudinal monitoring of HPV infection in patients with head and neck cancers, particularly oropharyngeal carcinoma (OPC), using a new electrochemical detection method. This method has already been successfully developed and validated for cervical cancer. The aim of the project is to monitor the dynamics of HPV viral load before the start of treatment and during conservative radiation therapy or concurrent chemoradiation therapy. HPV will be analyzed from oral swabs, oral cavity washings, and plasma as part of a small prospective study. The results of the new method will be correlated with standard techniques, particularly qPCR. Longitudinal monitoring may contribute to the individualization and potential de-escalation of treatment in selected patients.",[92],"Oropharyngeal Carcinoma (OPC)",[94],"HPV-positive head and neck tumors","2026-07-17",{"date":97,"type":98},"2026-07-22","ACTUAL",{"date":100,"type":98},"2026-05-25",{"date":102,"type":86},"2027-03",{"name":5,"class":6},1]