[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493862":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":31,"responsibleParty":88,"collaborators":90,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":11,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Centre Jean Perrin","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional","EXPERIMENTAL",null,[13],"Biological: Blood sample",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","Blood sample","The intervention consist in a blood sample that will be taken twice :\n\n* at the inclusion (before treatment)\n* 3 months after the radiochemotherapy in case of incomplete response (PET-CT)",[9],[21],{"name":22,"affiliation":5,"role":23},"Maureen BERNADACH, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Angeline GINZAC COUVÉ, PhD","CONTACT","0463663337","+33","angeline.ginzac@clermont.unicancer.fr",[32,51,66,77],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Centre Jean PERRIN","RECRUITING","Clermont-Ferrand","Puy-de-Dôme","63011","France","FR",{"type":41,"coordinates":42},"Point",[43,44],3.08682,45.77969,{"lat":44,"lon":43},[47,49],{"name":48,"role":27,"phone":11,"phoneExt":11,"email":30},"Angeline GINZAC COUVÉ",{"name":50,"role":23,"phone":11,"phoneExt":11,"email":11},"Maureen BERNADACH, Dr",{"facility":52,"status":53,"city":54,"state":11,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Centre Hospitalier Henri Mondor","NOT_YET_RECRUITING","Aurillac","15000",{"type":41,"coordinates":57},[58,59],2.43983,44.92539,{"lat":59,"lon":58},[62],{"name":63,"role":27,"phone":64,"phoneExt":11,"email":65},"Daniela BURLACU, MD","0471465656","D.burlacu@ch-aurillac.fr",{"facility":67,"status":34,"city":68,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Hôpital de la Croix-Rousse","Lyon",{"type":41,"coordinates":70},[71,72],4.84789,45.74906,{"lat":72,"lon":71},[75],{"name":76,"role":23,"phone":11,"phoneExt":11,"email":11},"Philippe CÉRUSE, Pr",{"facility":78,"status":34,"city":79,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"CHU de Saint-Étienne","Saint-Etienne",{"type":41,"coordinates":81},[82,83],4.39,45.43389,{"lat":83,"lon":82},[86],{"name":87,"role":23,"phone":11,"phoneExt":11,"email":11},"Yann LELONGE, Dr",{"type":89,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[91],{"name":92,"class":6},"GIRCI Auvergne Rhone-Alpes","100493862","prediction-of-residual-disease-by-circulating-dna-detection-after-potentiated-radiotherapy-for-locally-advanced-head-and-neck-cancer-100493862",false,"NCT05710679","Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer","NeckTAR","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 80 years\n* Histologically confirmed, never treated squamous cell carcinoma with lymph node involvement\n* squamous cell carcinoma p16+or p16-, stage III (N1), IVa or IVb (UICC classification 8th edition), N1 minimum, and oropharyngeal sqamous cell carcinomas p16+ stage I or II, N1 minimum, resectable but not operated or unresectable, with indication for concomitant or sequential radiochemotherapy with induction chemotherapy using Docetaxel, Platinum, 5-Fluorouracil (TPF or modified TPF according to the practices of the investigating centers)\n* Oral cavity, oropharynx, hypopharynx or larynx, cervical adenopathies without primary\n* Availability of FFPE samples prior to treatment initiation\n* Detection of circulating DNA in the initial blood sample\n* Obtaining informed consent from the patient\n* Affiliation to the French social security system\n\nExclusion Criteria:\n\n* Tumor of the nasopharynx, sinuses, nasal cavity, salivary glands or thyroid cancer\n* Treatment by exclusive radiotherapy\n* Contraindication to cervical lymph node dissection\n* Metastatic disease (stage IVc)\n* Previous treatment for head and neck cancer\n* History of other cancer in the last 3 years (except carcinoma in situ, basal cell skin carcinoma, localized prostate cancer Gleason 6)\n* Pregnant or breastfeeding woman\n* Patient under guardianship or curators\n* Psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial or compliance with the treatment","ALL","18 Years","80 Years",{"count":104,"type":105},63,"ESTIMATED","INTERVENTIONAL",[108],"NA","Sixty percent of newly diagnosed head and neck squamous cell carcinomas (HNSCCs) are at a locally advanced (LA) stage. Depending on tumor site, stage, and resectability, locoregional failure rates can range from 35% to 65%. The persistence of residual disease at the end of treatment is a major prognostic element but is not always reliably assessed by current imaging techniques. Up to 40-50% of patients have residual adenomegaly and only 30% have viable disease when further adenectomy is performed. Sensitive and reproducible detection of residual disease after treatment is a major challenge in this patient category.\n\n18F-fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET\u002FCT) guided surveillance, with a negative predictive value of 95-97%, has proven to be non-inferior to cervical curage in HNSCCs with residual adenomegaly. Cervical curage is now indicated only if the response assessed by PET-CT is incomplete. Nevertheless, the ability of PET-CT to predict treatment failure is unsatisfactory due to a high frequency of false positives, because of inflammatory changes, with a positive predictive value of about 20-50%.\n\nCirculating tumor DNA (ctDNA) may provide a more reliable assessment of response to potentiated radiotherapy. Liquid biopsy monitoring of response in patients treated with potentiated radiation therapy for locally advanced HNSCCs a has been shown to be feasible. In 85% of patients, ctDNA is detectable and correlates significantly with tumor volume and response to treatment. In addition, one study showed that post-radiotherapy analysis of circulating HPV16 viral DNA (cvDNA) in patients with HPV16-related HNSCCs complemented PET-CT and helped guide management decisions. HPV16 cvDNA and PET-CT have similar negative predictive values, whereas the positive predictive value is higher for HPV16 cvDNA (100% versus 50%). Nevertheless, current data are insufficient to allow routine use of this marker.\n\nThis is a multicenter, single arm, open study for patients with a locally advanced head and neck cancer for which a potentiated radiotherapy is indicated.",[111],"Locally Advanced Head and Neck Carcinoma","2026-05-21",{"date":114,"type":115},"2026-05-26","ACTUAL",{"date":117,"type":115},"2024-01-17",{"date":119,"type":105},"2031-07",{"name":5,"class":6},4]