[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"laryngeal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:laryngeal-cancer":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,100,139,170,193,215,236,269,296,339,361,385],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":77,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100210159","integrated-cancer-repository-for-cancer-research-100210159",false,"NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"ALL","19 Years","110 Years",{"count":21,"type":22},999999,"ESTIMATED","80 Years","OBSERVATIONAL","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Prostate Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Ovarian Cancer","Endometrial Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[27,28,78,79,80,81,82,83,84,85,65,86,75,76],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","RECRUITING","2026-06-25",{"date":90,"type":91},"2026-06-29","ACTUAL",{"date":93,"type":91},"2013-11-01",{"date":95,"type":22},"2099-12",{"name":97,"class":98},"University of Nebraska","OTHER",42,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":122,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100609025","phase-2-neoadjuvant-chemotherapy-and-programmed-cell-death-protein-1pd-1-inhibition-for-head-and-neck-cancer-treatment-de-escalation-neoscorch-hn-100609025","NCT07209189","Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)","Neoadjuvant Chemotherapy and PD-1 Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)","(NeoScorch HN)","Inclusion:\n\n* Eligible subjects must have histologically confirmed, locoregionally advanced head and neck or sinonasal, nasolacrimal, or skull base tumors and meet HPV testing requirements as outlined.\n* HPV-independent HNSCC (cT2-cT4, N0-N3) with potential for organ preservation using response-adapted surgery.\n* HPV-associated HNSCC with radiographic extranodal extension (cT1-cT3 tonsil or lateralized base of tongue, N0-N1, up to 4 nodes with rENE).\n* Sinonasal\u002Fskull base tumors, including: sinonasal carcinomas, HPV-associated sinonasal cancer, sinonasal undifferentiated carcinoma (e.g., Isocitrate dehydrogenase 2 (IDH2) mutant), or neuroendocrine sinonasal tumors (e.g., olfactory neuroblastoma) (cT2-cT4, N0-N3).\n* HPV16 type only. Patients with non-HPV16 cancers are not eligible. If p16 immunohistohemistry (IHC) positivity is the only result available at enrollment, neoadjuvant therapy may start while HPV nucleic acid testing is pending. Patients found to be HPV non-16 must discontinue study participation.\n* At least 8 unstained 5-µm slides must be available. If unavailable, a new biopsy is required unless waived by the PI.\n* Appropriate candidates for curative-intent therapy.\n* American Joint Committee on Cancer (AJCC) 7th edition: Stage III-IV, excluding N2c or bulky N2b\u002Fc (N3 equivalent) and bulky T4 (≥30cc).\n* AJCC 8th edition: Stage I with N1, Stage II, or Stage III, excluding N2 disease, bulky nodal disease (N3 equivalent), or bulky T4 (≥30cc).\n* Surgical arm: Candidates must be operable based on upfront imaging\u002Fexam. Patients with Grade 1 rENE may proceed to surgery; Grade 2\u002F3 rENE are excluded.\n* Measurable disease per RECIST 1.1.\n* No prior systemic therapy, radiotherapy, or investigational agents for the current cancer.\n* No complete surgical resection within 8 weeks of enrollment (biopsy or excision with residual disease acceptable).\n* Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky ≥70%.\n* Platelets ≥100,000\u002FµL.\n* Absolute Neutrophil Count (ANC) ≥1,500\u002FµL.\n* Hemoglobin ≥9 g\u002FdL (without recent transfusion\u002FEPO).\n* Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) \\\u003C2.5 × ULN.\n* Albumin ≥2.5 mg\u002FdL.\n* Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN if total \\>1.5 × ULN (Upper Limit of Normal).\n* Creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault or measured GFR).\n* International Normalized Ratio (INR)\u002F Prothrombin Time (PT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).\n* Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).\n* Must sign and understand a study-specific informed consent form.\n* Women of childbearing potential (WOCBP): Negative pregnancy test within 72 hours prior to first dose.\n* WOCBP must not be breastfeeding and must agree to use highly effective contraception during therapy and for 120 days after last dose.\n* Men: Must use adequate contraception during treatment and for 120 days after last dose; condom use required in addition to highly effective methods.\n* Azoospermic men and WOCBP not heterosexually active are exempt from contraception but must still undergo pregnancy testing.\n* Counseling on pregnancy prevention is mandatory.\n* Highly effective methods (\\\u003C1% failure rate with consistent use) must be used\n\nExclusion:\n\n* WOCBP with a positive urine pregnancy test within 72 hours before treatment allocation; if positive or inconclusive, a confirmatory serum pregnancy test is required.\n* Pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last dose.\n* Prior treatment with PD-1, PD-L1, PD-L2 inhibitors, or other agents targeting T-cell receptors (e.g., Cytotoxic T-lymphocyte antigen 4 (CTLA-4), OX40 (Tumor Necrosis Factor Receptor Superfamily Member 4), CD137).\n* Prior systemic anti-cancer therapy or radiotherapy for the current cancer. Surgery is allowed if adequately recovered from complications.\n* Radiotherapy within 2 weeks of study start. A 1-week washout is permitted for palliative, non-stereotactic radiation (≤2 weeks) to non-Central Nervous System (CNS), non-head and neck disease, provided there are no residual toxicities, no steroid requirement, and no history of radiation pneumonitis.\n* Live or live-attenuated vaccines within 30 days of first study dose (including live Corona Virus Disease (COVID-19) vaccines). Inactivated, Messenger ribonucleic acid (mRNA), and peptide vaccines are allowed.\n* Concurrent treatment with other investigational agents.\n* Participation in another investigational drug or device study within 4 weeks before first study dose, unless in follow-up phase only.\n* Diagnosis of immunodeficiency, or receiving chronic systemic steroids at doses \\>10 mg prednisone equivalent daily, or other immunosuppressive therapy within 7 days before study drug.\n* Active autoimmune disease requiring systemic treatment in the past 2 years. Physiologic replacement therapy (thyroxine, insulin, low-dose steroids for adrenal or pituitary insufficiency) is allowed.\n* History of severe hypersensitivity (≥Grade 3) to Toripalimab, its excipients, or other anti-PD-1 agents.\n* Additional active malignancy requiring treatment within 2 years, except basal\u002Fsquamous cell skin cancers, in situ cancers, low-grade tumors unlikely to affect survival within 3 years, or cancers treated with curative therapy.\n* Active CNS metastases or carcinomatous meningitis. Intracranial extension of the primary tumor is allowed. Patients with previously treated brain metastases may enroll if radiologically stable ≥4 weeks, clinically stable, and off steroids ≥14 days before study drug.\n* History of pneumonitis or interstitial lung disease requiring steroids, or current pneumonitis\u002FInterstitial Lung Disease (ILD).\n* Active infection requiring systemic therapy.\n* Known HIV infection.\n* Known active Hepatitis B (HBsAg positive) or active Hepatitis C (HCV RNA positive). Patients with cleared or eradicated Hepatitis B (HBV) or HCV are eligible.\n* Any condition, therapy, or abnormality that could confound study results, interfere with participation, or be judged by the investigator as not in the participant's best interest.\n* Known psychiatric illness or substance abuse that could interfere with study compliance. Stable chronic managed disorders are acceptable.\n* History of allogeneic tissue or solid organ transplant.\n* Significant cardiovascular disease, including congestive heart failure (NYHA Class III or IV), unstable angina, serious uncontrolled arrhythmia, myocardial infarction within 6 months, or prior myocarditis.","18 Years",{"count":110,"type":22},75,"INTERVENTIONAL",[113],"PHASE2","The NeoScorch HN study is a single institution multisite phase II trial including 3 cohorts of 25 patients each for patients with newly diagnosed locoregionally advanced, histologically confirmed, head and neck cancer eligible for curative-intent treatment, who will receive neo-adjuvant chemoimmunotherapy-based treatment as well as standard of care adjuvant treatment. The three cohorts include three different aspects of surgical de-escalation in head and neck cancer. The first cohort includes human papillomavirus independent (HPV-) squamous cell carcinoma of the head and neck. The second cohort includes HPV-associated head and neck cancer with radiographic evidence of extranodal extension in neck lymphadenopathy. The third cohort specifically includes malignancies of the sinonasal cavity and skull base which have a propensity for invasion of the orbit, skull base, and maxilla. Surgical treatment of all three of these cohorts has significant morbidity including swallowing, speech, and vision among others.",[116,117,55,57,53,118,119,120,121],"Head and Neck Cancer","Squamous Cell Carcinoma","Sinonasal Squamous Cell Carcinoma","HPV (Human Papillomavirus)-Associated Carcinoma","Skull Base Tumors","HPV 16 Positive Oropharyngeal Tumors (OPC)",[123,124,125,126,127,128],"head and neck cancer","oral cancer","oropharyngeal cancer","laryngeal cancer","HPV associated","squamous cell carcinoma","2026-04-21",{"date":131,"type":91},"2026-04-23",{"date":133,"type":91},"2026-02-18",{"date":135,"type":22},"2030-12-01",{"name":137,"class":98},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",1,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":16,"sex":17,"minAge":108,"maxAge":147,"enrollmentInfo":148,"targetDuration":150,"studyType":24,"phases":4,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":138},"100633888","a-machine-learning-based-risk-prediction-model-for-head-and-neck-cancerous-lesions-100633888","NCT07532538","A Machine Learning-Based Risk Prediction Model for Head and Neck Cancerous Lesions","A Machine Learning-Based Risk Prediction Model for Head and Neck Cancerous Lesions: A Multidimensional Feature Study Integrating Demographics and Clinical Symptomatology","ML-HNC-Risk","Inclusion Criteria:\n\nAge ≥ 18 years old. Patients with complete clinical data information and laryngoscopic images.\n\nExclusion Criteria:\n\nRefusal to sign the informed consent form. Incomplete clinical data. Known diagnosis of other head and neck malignancies (thyroid cancer, malignant parotid tumors, etc.","100 Years",{"count":149,"type":22},3000,"6 Months","This study aims to develop and validate a clinical prediction model for the risk of head and neck cancerous lesions using deep learning combined with AI algorithms, based on multi-center clinical data.",[52,53,116],[154,155,156,157,158,159],"Head and neck malignant lesions","Hypopharyngeal cancer","Laryngeal cancer","AI","machine learning","AI-assisted diagnosis","NOT_YET_RECRUITING","2026-04-12",{"date":163,"type":91},"2026-04-16",{"date":165,"type":22},"2026-04-30",{"date":167,"type":22},"2030-11-30",{"name":169,"class":98},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":138},"100522057","workshops-and-exchange-groups-for-laryngectomized-patients-100522057","NCT06077643","Workshops and Exchange Groups for Laryngectomized Patients","GELAT","Inclusion Criteria:\n\n* Have had a total laryngectomy at Bichat Hospital or HEGP within the last four years\n* Have completed all the specific care of the pathology that required the total laryngectomy\n* Be able to travel to Bichat Hospital for all four sessions\n* Be over 18 years of age\n* Have received informed information about the conduct of the research.\n\nExclusion Criteria:\n\n* WHO simplified autonomy scale greater than 2, i.e. from normal activity to ambulant and able to take care of themselves, but unable to provide work and bedridden for less than 50% of their time\n* Patient who does not speak or understand French\n* Lack of affiliation to a social security scheme or CMU\n* Patient benefiting from legal protection measures (guardianship or curatorship)\n* Patient who has communicated an objection to their inclusion, after informed information.",{"count":178,"type":22},50,"This research is conducted with the aim of improving the quality of life of laryngectomized patients and their entourage. Worldwide, there are 185,000 new cases of laryngeal cancer per year. In Europe, between 2000 and 2007, the crude annual incidence rates of these cancers were 4.6\u002F100,000 with a 5-year survival rate of 61%.\n\nIn France, about 30 to 35% of cancers of the upper aerodigestive tract are localized to the larynx, or about 43,000 cases per year. Most patients are men (89%) between 50 and 70 years old. One of the treatments for these cancers is to perform an excision of the larynx thus removing the entire tumor, it is the total laryngectomy. The trachea is thus permanently removed from the skin and the digestive tract becomes independent.",[181,53],"Laryngectomy; Status",[183],"Laryngectomy","2026-03-26",{"date":186,"type":91},"2026-03-27",{"date":188,"type":91},"2023-10-10",{"date":190,"type":22},"2026-10-10",{"name":192,"class":98},"Assistance Publique - Hôpitaux de Paris",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":200,"targetDuration":202,"studyType":24,"phases":4,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":4},"100617876","validation-of-end-to-end-difficult-airway-pathway-planning-algorithm-eap-lc-100617876","NCT07324317","Validation of End-to-End Difficult Airway Pathway Planning Algorithm (EAP-LC)","A Prospective Clinical Validation Study of an End-to-End Difficult Airway Pathway Planning Algorithm (EAP-LC) in Patients With Laryngeal Cancer: A Spatial Consistency Assessment Based on Awake Flexible Bronchoscopic Intubation Videos","Inclusion Criteria:\n\n* Patients scheduled to undergo laryngeal cancer surgery under general anesthesia, including supraglottic, glottic, and subglottic laryngeal cancers, as well as lesions involving the hypopharynx-larynx junction, who are assessed preoperatively as requiring awake flexible bronchoscopic intubation. Eligible participants must meet all of the following criteria: age ≥ 18 years, with no restriction on sex; a confirmed diagnosis of laryngeal cancer or laryngeal tumor based on previous or preoperative imaging and\u002For pathological findings; a planned laryngeal surgical procedure; a preoperative anesthetic assessment indicating the need for awake flexible bronchoscopic intubation to ensure airway safety; completion of contrast-enhanced laryngeal and\u002For cervical computed tomography (CT) within 2 weeks prior to surgery, with image quality adequate for analysis by the EAP-LC algorithm; clear consciousness, the ability to understand the study procedures, and voluntary provision of written informed consent.\n\nExclusion Criteria:\n\n* Patients will be excluded if they meet any of the following conditions: inability to cooperate with awake intubation due to severe anxiety, cognitive impairment, or psychiatric disorders; a history of total laryngectomy or loss of normal laryngeal anatomical structures that precludes oral or nasal flexible bronchoscopic intubation; severe coagulation disorders or an uncontrollable risk of bleeding; or any other condition deemed by the investigators to make participation inappropriate, such as refusal of video recording or special confidentiality requirements.",{"count":201,"type":22},70,"1 Day","Patients with laryngeal cancer often present with varying degrees of airway narrowing or anatomical distortion, making airway management particularly challenging. Awake flexible bronchoscopic intubation is a widely accepted and important strategy to ensure airway safety in this population. Currently, the selection of the intubation pathway mainly relies on visual assessment of preoperative computed tomography (CT) images and the clinical experience of anesthesiologists, lacking objective and quantifiable tools for airway pathway planning.\n\nOur research group has developed an end-to-end airway pathway planning algorithm for laryngeal cancer patients (EAP-LC), which can automatically generate predicted nasal or oral intubation pathways based on preoperative pharyngeal and upper airway CT images. Preliminary simulation analyses based on retrospective CT data demonstrated that the algorithm is capable of identifying airway narrowing and generating trajectories that are close to clinically feasible intubation paths (preliminary data, under review). However, to date, no study has directly compared the algorithm-predicted pathways with actual intubation trajectories obtained during awake flexible bronchoscopic intubation. Therefore, a prospective clinical validation study is required to evaluate the spatial consistency and clinical feasibility of the EAP-LC algorithm.\n\nWithout altering routine clinical treatment or anesthetic management, this study aims to evaluate the clinical accuracy, safety, and feasibility of the EAP-LC algorithm by comparing the intubation pathways predicted from preoperative CT images with the real-world trajectories recorded during awake flexible bronchoscopic intubation. The results of this study are expected to provide a more precise and objective decision-support tool for airway management in patients with laryngeal cancer.",[53,205],"Difficult Airway","2025-12-24",{"date":208,"type":91},"2026-01-07",{"date":210,"type":22},"2026-01-01",{"date":212,"type":22},"2026-06-30",{"name":214,"class":98},"Eye & ENT Hospital of Fudan University",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":233,"locationsCount":235},"100507951","the-voice-as-a-tool-to-detect-recurrence-of-laryngeal-and-hypopharyngeal-cancer-100507951","NCT05894070","The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer","The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer (VoiceDetect) - a Feasibility Study","VoiceDetect","Inclusion Criteria:\n\n1. Histopathologically proven carcinoma in-situ or invasive LSCC or HPSCC (in non-surgically treated carcinoma: clinical\u002Fradiologic stage I-IV (excluding M1) according to the Union for International Cancer Control (UICC) \u002F Tumor (T), Nodes (N), and Metastases (M) (TNM) 8th ed.; in surgically treated carcinoma: pathological stage I-IV (excluding M1) according to the UICC \u002F TNM 8th ed.).\n2. ≥ 18 years of age.\n3. Treatment with curative intent, regardless of treatment modality (mono- or multimodal).\n\n   Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before\u002Fafter the diagnosis of LSCC\u002FHPSCC) non-laryngeal\u002F-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and\u002For basal cell carcinoma of the skin and\u002For other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.\n4. Clinical confirmation of complete remission of LSCC or HPSCC through Ear, Nose and Throat (ENT) examination, including fiberendoscopy of the pharynx and larynx, at the time of enrolment, during the period of eligibility (6 to 30 months after treatment).\n\n   Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before\u002Fafter the diagnosis of LSCC\u002FHPSCC) non-laryngeal\u002F-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and\u002For basal cell carcinoma of the skin and\u002For other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.\n5. Informed consent as documented by signature.\n\nExclusion Criteria:\n\n1. Total laryngectomy as primary therapy.\n2. Any local, regional, and systemic laryngeal or hypopharyngeal cancer persistence\u002Fprogression, or recurrence before enrolment.\n\n   Excepted: Patients with synchronous laryngeal\u002Fhypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible.\n3. Any local, regional, and systemic tumor persistence\u002Fprogression, or recurrence of synchronous (larynx and hypopharynx included) or metachronous (before\u002Fafter the diagnosis of LSCC\u002FHPSCC) non-laryngeal\u002F-hypopharyngeal malignant tumors within 6 months before enrolment.\n\n   Excepted: Patients with surgically treated progredient or recurrent locally defined Tis-2 N0 M0 squamous cell carcinoma and\u002For basal cell carcinoma of the skin and\u002For non-head and neck progredient or recurrent Tis.\n4. Any previously treated LSCC\u002FHPSCC or treated second primary malignancies of the larynx or hypopharynx before the diagnosis and treatment of the investigated LSCC\u002FHPSCC (= index tumor).\n5. Presence of any medical, psychological, familial, sociological, or geographical conditions expected to potentially hamper the compliance with the study protocol.\n6. Inability to follow procedures (e.g., inability to read) or insufficient knowledge of any project language (German and French).",{"count":224,"type":22},100,"The investigators will obtain three-monthly voice recordings and fiberendoscopic examinations of the larynx\u002Fhypopharynx for a minimal period of 6 months from all laryngeal\u002Fhypopharyngeal squamous cell carcinoma (LSCC\u002FHPSCC) patients, who have successfully completed curative primary treatment, except those who underwent total laryngectomy. Furthermore, the investigators will ask the patients to fill out the voice handicap index-30 questionnaire (VHI-30) during each study visit. The VHI-30 allows to make a subjective assessment of the patients' own vocal problem. The primary objective is to assess the feasibility and compliance of longterm regular voice monitoring in LSCC and HPSCC follow-up.",[53,52],"2025-07-24",{"date":229,"type":91},"2025-07-29",{"date":231,"type":91},"2023-08-02",{"date":212,"type":22},{"name":234,"class":98},"Insel Gruppe AG, University Hospital Bern",2,{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":111,"phases":246,"briefSummary":248,"conditions":249,"keywords":253,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":138},"100574642","phase-1-thermoradiotherapy-for-locally-advanced-head-and-neck-cancer-patients-100574642","NCT06761937","Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients","Thermoradiotherapy for Locally Advanced Head and Neck CAncer Patients - a Phase I Trial.","TANCA-I","Inclusion Criteria:\n\n* Age \\>= 18 years\n* WHO 0-1\n* Mouth opening before treatment of \\>= 40 mm for women and \\>= 45mm for men\n* Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx proven by cytology \u002F histology.\n* Locally advanced disease (stage III-IV).\n* Curative intend treatment with radiotherapy in the primary setting with a contraindication for systemic adjuvant treatment.\n* Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patients previously treated by radiation on the same target volume.\n* Any condition or circumstance potentially hampering compliance with the follow-up schedule.\n* Patients having pacemakers or clustered metal markers (with a total length \\>2 cm of metal markers in direct contact).\n* Tumor location caudal to a tracheostomy (this prevents penetration of the microwaves to the tumor).\n* Anatomical boundaries of the shoulders prohibiting positioning of the applicator.",{"count":245,"type":22},30,[247],"PHASE1","Patients with head and neck cancer treated with radiotherapy (RT) have a substantial change of recurrence of the tumor in the pharynx or lymph nodes in the neck. Once tumor and\u002For lymph nodes have recurred, the prognosis is poor. To increase the efficacy of RT, usually chemotherapy is added to the treatment. However, due to age or co-morbidity chemotherapy is not always feasible to give in all patients. In head and neck patients unfit for chemotherapy, there is a clinical need to increase the effectiveness of RT, without adding substantial toxicity. To this end, the use of thermotherapy in this disease site is investigated.\n\nThe goal of this clinical trial is to learn about the recommended dose of thermotherapy in addition to radiotherapy for patients with head and neck cancer. This recommended dose is the dose that is tolerable and does not give additional side effects.\n\nThe main question our study aims to answer is:\n\n\"What is the recommended dose of thermotherapy for patients with primary head and neck cancer treated with radiotherapy?\"\n\nParticipants will receive thermotherapy once a week in addition to the standard radiotherapy. Researchers will investigate if side effects occur during the treatment and until 6 months after the last treatment has been given.\n\nThe thermotherapy will be applied using a device that was made in Erasmus MC and allows for precise heating of the tumor and lymph nodes.",[116,250,251,53,252],"Oropharyngeal Carcinoma","Hypopharyngeal Carcinoma","Head and Neck Squamous Cell Carcinoma",[254,255,256,257,258,259],"Hyperthermia","Thermotherapy","Clinical Trial","Thermoradiotherapy","Phase 1 trial","Radiosensitization","2025-07-22",{"date":262,"type":91},"2025-07-25",{"date":264,"type":91},"2025-05-01",{"date":266,"type":22},"2028-10-31",{"name":268,"class":98},"Erasmus Medical Center",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":111,"phases":278,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":138},"100563051","phase-2-sbrt-followed-by-chemoimmunotherapy-of-toripalimab-plus-docetaxel-and-cisplatin-for-larynx-preservation-in-patients-with-locally-regionally-advanced-squamous-cell-carcinoma-of-the-larynx-and-hypopharynx-100563051","NCT06611137","SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx","Inclusion Criteria:\n\n* Laryngeal (T3-4N0-3M0 ) and hypopharyngeal ( T2-4N0-3M0) cancers staged by AJCC8th\n* age 18-70\n* PS score 0-1\n* normal functions to tolerate chemotherapy, immunotherapy and radiotherapy\n\nExclusion Criteria:\n\n* Patients with a combination of other malignant tumours\n* Individuals with contraindications to immunotherapy","70 Years",{"count":277,"type":22},35,[113],"This trial aims to evaluate the safety and efficiency of SBRT followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx",[53,281],"Hypopharynx Cancer",[283,284,285,126,286],"SBRT","immunotherapy","larynx preservation","hypopharynx cancer","2024-09-25",{"date":289,"type":91},"2024-09-26",{"date":291,"type":91},"2024-09-11",{"date":293,"type":22},"2027-09-11",{"name":295,"class":98},"Sun Yat-sen University",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":275,"enrollmentInfo":304,"targetDuration":4,"studyType":111,"phases":306,"briefSummary":307,"conditions":308,"keywords":319,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":338},"100526640","phase-2-european-larynx-organ-preservation-study-elos-mk-3475-c44-100526640","NCT06137378","European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]","ELOS - Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiation Compared to Additional PD-1 Inhibition in CPS ≥1 Advanced Laryngeal\u002FHypopharyngeal Cancer Suitable for Laryngectomy Selected After Early Response Evaluation","ELOS","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male and female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of squamous cell carcinoma (SCC) of the larynx or hypopharynx according to the decision of the multidisciplinary tumor board suitable for total laryngectomy can be enrolled in this study.\n2. Stage III, IVA or IVB, whenever clear resection margins R0 \\>5 mm can be achieved and no radiologic signs of extranodal extension of neck nodes are present.\n3. Have provided newly obtained excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.\n4. PD-L1-expression\\* within the tumor biopsy, CPS ≥1\n5. Male participants:\n\n   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n6. Female participants:\n\n   A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n   1. Not a woman of childbearing potential (WOCBP) OR\n   2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation\u002Frandomization.\n8. Have adequate organ function as defined in the (Table 4) of the protocol. Specimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory receptor on T or NK cells (e.g., CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-cancer therapy including investigational agents.\n4. Has received prior radiotherapy.\n5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n9. Has known distant metastases including active CNS metastases and\u002For carcinomatous meningitis.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n12. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n13. Has an active infection requiring systemic therapy.\n14. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.\n15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n16. Has a known history of active TB (Bacillus Tuberculosis).\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n20. Has had an allogenic tissue\u002Fsolid organ transplant.\n21. Has a known intolerance to one of the substances administered during treatment including e.g. antibiotics, antiemetics, etc. or any other component of concurrent auxiliary medication.",{"count":305,"type":22},140,[113],"ELOS is a prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicentre trial in local advanced stage III, IVA\u002FB head and neck squamous cell carcinoma of the larynx or hypopharynx (LHNSCC) with PD-L1-expression within tumor tissue biopsy, calculated as CPS ≥ 1 curable by total laryngectomy. Induction chemotherapy (IC) with Docetaxel and Cisplatin (TP) followed by radiation will be compared to additional PD-1 inhibition. Patients will be selected after short induction early response evaluation after the first cycle IC (IC-1) aiming on larynx organ-preservation by additional 2 cycles IC followed by radiotherapy (69.6 Gy) for responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥ 30%. Nonresponders (ETSS \\\u003C 30% or progressing disease) will receive total laryngectomy and selective neck dissection followed by postoperative radiation or chemoradiation according to the recommendation of the clinics multidisciplinary tumor board. However, Patients randomized into the intervention arm starting day 1 will receive 200 mg Pembrolizumab (MK-3475) i.v. in 3-week cycle (q3w) for 17 cycles (12 months). Treatment with pembrolizumab will continue in the experimental arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent from subsequent decision on adjuvant therapy after TL.",[309,310,311,312,313,314,315,316,317,181,53,318],"Squamous Cell Carcinoma of Head and Neck","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma Stage III","Laryngeal Squamous Cell Carcinoma Stage IV","Squamous Cell Carcinoma of Larynx","Squamous Cell Carcinoma of the Larynx","Squamous Cell Carcinoma of the Larynx Stage III","Squamous Cell Carcinoma of the Larynx Stage IV","Laryngeal Squamous Cell Carcinoma","Laryngeal Neoplasms",[320,321,322,323,324,325,326,327,328],"induction chemotherapy","neoadjuvant treatment","immune checkpoint inhibitor","pembrolizumab","KEYNOTE","larynx organ preservation","laryngectomy-free survival","overall survival","event-free survival","2024-09-18",{"date":331,"type":91},"2024-09-20",{"date":333,"type":91},"2024-04-17",{"date":335,"type":22},"2030-12",{"name":337,"class":98},"University of Leipzig",9,{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":275,"enrollmentInfo":346,"targetDuration":4,"studyType":111,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":138},"100558661","phase-2-tislelizumab-and-induction-chemotherapy-for-larynx-preservation-in-resectable-advanced-laryngealhypopharyngeal-cancer-100558661","NCT06554028","Tislelizumab and Induction Chemotherapy for Larynx Preservation in Resectable Advanced Laryngeal\u002FHypopharyngeal Cancer","Tislelizumab and Induction Chemotherapy Followed by Radiotherapy or Adaptive Surgery for Larynx Preservation in Resectable Locally Advanced Laryngeal or Hypopharyngeal Cancer: A Single-Arm Phase II Clinical Trial","Inclusion Criteria:\n\n1. Pathologically confirmed, resectable locally advanced laryngeal\u002Fhypopharyngeal squamous cell carcinoma (T2-4a, N0-resectable N3, M0);\n2. Age between 18-70 years;\n3. Had at least one measurable lesion according to RECIST 1.1 criteria;\n4. Anticipated overall survival more than 3 months;\n5. Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;\n6. Normal organ function;\n7. Male and no pregnant female, able to adapt birth control methods during treatment;\n8. Signed inform consent;\n\nExclusion Criteria:\n\n1. Hypersensitivity to tislelizumab, Paclitaxel or Cisplatin.\n2. Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy.\n3. Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.\n4. There is distant metastasis.\n5. Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but excludes autoimmune-mediated hypothyroidism on stable doses of thyroid replacement hormone; type 1 diabetes on stable doses of insulin; vitiligo or resolved childhood asthma\u002Fallergies, Patients who do not require any intervention after adulthood.\n6. Known history of primary immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation);\n7. Severe infection occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.\n8. The subject has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA grade II or echocardiography，showing left ventricular ejection fraction (LVEF) \\\u003C 50%; unstable angina; myocardial infarction within 1 year; patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical，intervention (including QTc interval ≥ 470 ms); uncontrolled diabetes, uncontrolled Patients with high blood pressure, hypertensive crisis or hypertensive encephalopathy or other diseases considered by the researchers to be ineligible.\n9. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU\u002Fml, or patients with active hepatitis C virus (HCV) should be excluded; inactive hepatitis B surface Antigen carriers, treated and stable hepatitis B patients (HBV DNA\\\u003C500IU\u002Fml), and cured hepatitis C patients can be enrolled.\n10. Have a history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with hormones) and non-infectious pneumonia.\n11. Active tuberculosis infection was found through medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment.\n12. Patients who have received any of the following treatments (1) Subjects who need to be given corticosteroids (\\> 10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies and nausea, Cases of use of corticosteroids for vomiting. In the absence of active autoimmune disease, corticosteroid replacement with inhaled or topical steroids and curative doses of prednisone \\>10 mg\u002Fday is permitted; (2) Have been vaccinated against tumors; those who have been vaccinated or have been vaccinated with live vaccines within 4 weeks before the first administration of the study drug; (3) Received major surgery or severe trauma within 4 weeks before the first use of the study drug; (4) Enrolled in another clinical study at the same time.\n13. Pregnant and lactating women. Women of childbearing age must take a pregnancy test within 7 days before enrollment Negative.\n14. Substance abuse, clinical or psychological or social factors that hinder informed consent or research conduct influences.\n15. Any uncertain factors affecting the safety or compliance of the subjects.",{"count":347,"type":22},46,[113],"This study is a prospective, single-arm, single-center, phase II study. The goal of this clinical trial is to explore the therapeutic value of the treatment model of \"tislelizumab combined with chemotherapy followed by radiotherapy\u002Fadaptive surgery\" on larynx Preservation of locally advanced hypopharyngeal cancer and laryngeal cancer.",[53,281,318],"2024-08-12",{"date":353,"type":91},"2024-08-14",{"date":355,"type":22},"2024-08",{"date":357,"type":22},"2027-12",{"name":359,"class":360},"Henan Cancer Hospital","OTHER_GOV",{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":384},"100468091","immune-biomarker-study-for-head-and-neck-cancer-100468091","NCT05375266","Immune Biomarker Study for Head and Neck Cancer","ImmunBio-KHT","Inclusion Criteria:\n\n* Initial diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx in stage UICC II-IVB (study group)\n* Diseases other than malignant diseases (patients with the indication for surgery of the ear, nose nose or maxillofacial surgery) (control group)\n* Absence of a currently existing or previous malignant disease regardless of the anatomical localization (control group)\n* Agreement of the patients for sampling blood, saliva and stool as well as consent to the preservation of all samples for further study purposes\n* Age ≥ 18 years\n* Cognitive ability of the patients to understand the meaning and purpose of the study and agree to it\n\nExclusion Criteria:\n\n* Distant metastases and \u002F or simultaneous secondary carcinoma at the time of diagnosis (= inclusion date)\n* Carcinomas in which it is (likely) impossible to take a sample without interfering with the further pathological assessment\n* Present drug abuse\n* Patients who are unable or unwilling to behave and receive treatment according to protocol\n* Patients who are legally patronized\n* Patients who are not eligible for participation in the study due to language barrier",{"count":369,"type":22},1100,"The aim of this prospective non-interventional multi-center trial is to study the prognostic value of intratumoral and systemic immune biomarkers in newly diagnosed non-metastatic head and neck cancer. Furthermore, the local immunological processes in the tumor will be correlated with the systemic immune status determined in the peripheral blood to identify prognostic immune signatures. In addition, tumor organoids will be generated ex vivo for functional biological analyses. The main objective is to create a prognostic score determined by clusters based on tumor immunologic criteria.",[116,55,57,52,53],[373,374],"Immunologic markers","Immunotherapy","2023-05-16",{"date":377,"type":91},"2023-05-17",{"date":379,"type":91},"2022-05-16",{"date":381,"type":22},"2027-03-31",{"name":383,"class":98},"University of Erlangen-Nürnberg Medical School",3,{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":111,"phases":395,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":138},"100412466","aortic-laryngeal-rehabilitation-graft-100412466","NCT04650919","Aortic Laryngeal Rehabilitation Graft","Placement of a Laryngeal Allograft Aortic Implant After Total Laryngectomy to Rehabilitate Laryngeal Function","GRAAL","Inclusion Criteria:\n\n* Patient with carcinomatous pathology of the upper airways requiring total laryngectomy\n* Patient affiliated to a social health insurance scheme (beneficiary or beneficiary's successor)\n* Patient speaks and reads French, understands the objectives and risks of the research and is able to provide dated and signed informed consent.\n* Patient having been informed of the results of the prior medical examination\n* For a woman with the ability to procreate: negative blood pregnancy test (verified during preoperative blood work) and effective contraception throughout the study.\n\nExclusion Criteria:\n\n* Patient with a contraindication to general anaesthesia and\u002For iodinated contrast agents\n* Breastfeeding woman\n* Patient with a WHO performance index of grade strictly greater than 2 at the inclusion visit\n* Patient with subglottic or basi-lingual tumour extension greater than 1 cm (by endoscopic control and CT scan)\n* Patient having undergone cervico-facial radiotherapy prior to surgical management\n* Patient suffering from severe coagulation disorders (checked during the blood test performed as part of the standard care to make the diagnosis of cancer)\n* Patient with a history of allergy to DMSO, DHEA, clindamycin, gentamicin, vancomycin used for graft treatment and preservation\n* Inability to give informed information about the patient (patient in emergency situations, difficulties in understanding the patient)\n* Patient in exclusion period (determined by a previous or ongoing study)\n* Patient under safeguard of justice\n* Patient under guardianship,curatorship, family guardianship\n* Any situation considered by the operating physician as falling under a non-inclusion criterion\n* Patient suffering from a decompensated psychiatric pathology or at risk of decompensation, which may interfere with the follow-up modalities in the research setting.",{"count":394,"type":22},4,[396],"NA","The larynx is a cartilaginous organ of the respiratory system located in the throat, which plays an essential role in respiratory function, swallowing and sound production.\n\nIn the case of advanced tumours, the surgical option most often remains total laryngectomy, with the corollary of a major impact on quality of life, not so much because of the loss of voice, but because of the presence of a definitive tracheostoma with particularly deleterious consequences.\n\nThe majority of the work of the different teams around the world has focused on restoring phonatory function, but no technique - apart from the artificial larynx developed in the ENT department of the Hautepierre Hospital - has yet succeeded in removing the tracheotomy orifice, requiring the restoration of a common passage between the respiratory and swallowing passages. If nutrition and phonatory function can still be supplemented after such an operation (oesophageal rehabilitation, implant placed between the trachea and oesophagus), natural breathing is no longer possible. Patients are forced to wear a permanent tracheotomy opening.\n\nThere are currently only 2 ways to try to restore all the functions of the larynx after total laryngectomy: i) laryngeal transplantation, but this procedure requires maintaining immunosuppressive treatment, which is not possible in patients suffering from cancer of the larynx, which is not a vital organ, ii) artificial larynx made of biomaterials (titanium), the first cases of which were performed worldwide in the ENT department of the Strasbourg University Hospital in 2012, results published in the NEJM (API 2008-2009 HUS No. 4493- IDRCB No.: 2011-A00032-39. However, difficulties were encountered with the use of the titanium prosthesis due to the bulk and rigidity of the removable and non-removable part, which caused residual swallowing difficulties (false routes).\n\nIt is now possible, due to the development of new allograft techniques in humans for tracheal replacement (studies published on a large number of cases with several years of hindsight, cf. references), to switch to the \"all biological\" using an aortic graft stented with a silicone stent. We wish to use these grafts in laryngeal restoration after total laryngectomy by our team, while exploiting all the data and experience acquired (unique in the world) within the ENT department of Hautepierre Hospital. This new conceptual leap should make it possible to significantly improve the patient's quality of life and the performance previously acquired in clinical trials on the artificial larynx in its entirety (breathing, phonation) or partially (swallowing).\n\nThe investigators thus propose to evaluate this new artificial larynx in aortic allograft, the objective of which is to supplement the respiratory, swallowing and phonation functions in patients laryngectomized for carcinological causes.",[53,399],"Total Laryngectomy",[401],"laryngectomy","2022-12-12",{"date":404,"type":91},"2022-12-13",{"date":406,"type":91},"2021-03-29",{"date":408,"type":22},"2026-07-28",{"name":410,"class":98},"University Hospital, Strasbourg, France"]