[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-cell-carcinoma-of-the-oropharynx\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-cell-carcinoma-of-the-oropharynx":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,44,74,95,118,144,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100518430","phase-2-de-intensification-of-postoperative-radiotherapy-in-patients-with-squamous-cell-carcinoma-of-the-head-and-neck-100518430",false,"NCT06030440","De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck","DIREKHT2","Inclusion Criteria:\n\n1. Histologically proven squamous cell carcinoma of the oral cavity\u002Flarynx\u002Foro-or hypopharynx (except glottis cancer (pT1\u002F2pN0))\n2. Surgery of primary tumor and neck dissection performed according to predefined surgical standard\n3. Indication for postoperative radio(chemo)therapy\n4. No lymph node metastases \\> 6cm\n5. Lymph node metastases in not more than 3 lymph node level\n6. No distant metastases (cM0)\n7. Age ≥ 18 years, no upper age limit\n8. Eastern Cooperative Oncology Group (ECOG) ≤ 2\n9. Patients who understood protocol contents and are able to behave according to protocol\n10. Signed study-specific consent form prior to therapy\n11. Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications)\n\nExclusion Criteria:\n\n1. macroscopic incomplete resection R2\n2. Distant metastases (cM1)\n3. Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)\n4. Lymph node metastases in \\> 3 lymph node level\n5. pregnant or lactating\u002Fnursing women\n6. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment\n7. Any condition potentially hampering compliance with the study protocol and follow-up schedule\n8. On-treatment participation on other clinical therapeutic trials\n9. Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant\u002Finduction))\n10. Patients who have contraindication for MRI and CT with contrast agent (both)\n11. Prior (\\> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage\n12. History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before diagnosis of head and neck cancer, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease","ALL","18 Years",{"count":19,"type":20},508,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This randomized, prospective, multicenter phase II\u002FIII trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.",[27,28,29,30],"Squamous Cell Carcinoma of the Oral Cavity","Squamous Cell Carcinoma of the Larynx","Squamous Cell Carcinoma of the Hypopharynx","Squamous Cell Carcinoma of the Oropharynx","RECRUITING","2026-03-11",{"date":34,"type":35},"2026-03-13","ACTUAL",{"date":37,"type":35},"2024-01-26",{"date":39,"type":20},"2033-09",{"name":41,"class":42},"University of Erlangen-Nürnberg Medical School","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100513190","phase-2-hpv-dna-guided-radiotherapy-de-intensification-of-head-and-neck-squamous-cell-carcinoma-100513190","NCT05962242","HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma","Circulating Tumor Modified HPV DNA-Guided Radiotherapy De-intensification of the Elective Neck (RaDEN) in Squamous Cell Carcinoma of the Head and Neck","HN001","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, ≥ 18 years of age\n4. Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx of any AJCC 8th edition stage.\n5. Eligible for and planning to receive definitive treatment or adjuvant treatment with radiotherapy.\n6. Participants who are receiving concurrent systemic anticancer therapy (e.g. chemotherapy or immunotherapy) for oropharyngeal cancer are eligible.\n\n   1. For participants with T1-2 and N0 disease, chemotherapy is not required for eligibility. Participants may or may not receive chemotherapy per physician discretion.\n   2. For participants with T3-4 and\u002For N+ disease, chemotherapy is required for eligibility.\n7. Participants may receive investigational agents with prior approval from the Principal Investigator.\n8. ECOG Performance Status of 0-2.\n9. p16 positive HPV as determined by NavDx and immunohistochemistry\n10. For females of reproductive potential: agreement to use adequate contraception during radiation treatment and for 6 months (or more if applicable based on other medications) after the end of radiation treatment.\n\nExclusion Criteria:\n\n1. Evidence of distant metastatic disease\n2. Prior history of radiotherapy to the head and\u002For neck\n3. Had surgery for oropharyngeal cancer within 8 months of enrollment unless it was an incomplete oncologic surgery. Participant is eligible if the gross tumor was not completely removed.\n4. Diagnosis of T3-4 and\u002For N+ disease with no plans to receive concurrent chemotherapy.\n5. Diagnosis of a current or prior invasive malignancy (except non-melanoma skin cancer) unless the participant has been disease free for at least 3 years.\n6. Participant is a prisoner\n7. Known contraindications to head and neck radiation therapy such as ataxia telangiectasia or scleroderma.\n8. Pregnancy or lactation\n9. Active or severe co-morbidities as defined by the following:\n\n   1. Unstable angina and\u002For congestive heart failure requiring hospitalization up to 180 days before registration\n   2. Transmural myocardial infarction up to 180 days before registration\n   3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n   4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\n   5. Hepatic insufficiency as determined by the treating clinician resulting in clinical jaundice and\u002For coagulation effects or severe liver dysfunction.\n   6. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be slightly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.\n10. Tobacco smoking history of 10 pack years or greater, or ≥ 20 pack years if smoking cessation occurred at least 1 year prior to enrollment\n11. Current use of antineoplastic drugs for other malignancies.",{"count":53,"type":20},90,[23],"The study will evaluate the safety and effectiveness of a lower than standard dose of radiation for definitive or adjuvant treatment of head and neck squamous cell carcinomas.",[30],[58,59,60,61,62,63],"Radiation Therapy","Radiotherapy","Head Cancer","Neck Cancer","Low Dose Radiation","HPV","2026-02-03",{"date":66,"type":35},"2026-02-05",{"date":68,"type":35},"2024-06-28",{"date":70,"type":20},"2029-11-01",{"name":72,"class":42},"University of Virginia",5,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":43},"100507952","phase-2-a-phase-ii-study-for-p16-oropharyngeal-cancer-personalized-de-escalation-treatment-at-university-of-michigan-customize-100507952","NCT05894083","A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)","Inclusion Criteria:\n\n* Patients must have FDG-avid (maximum SUV ≥ 4.0) (from PET scan of any date, any scanner) and histologically or cytologically proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate) or unknown primary that is p16 positive by immunohistochemistry or HPV positive by in situ hybridization\n* Clinical stage: Stage I-II AJCC 8th edition staging\n* Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:\n\n  * History\u002Fphysical examination, including documentation of weight within 4 weeks prior to registration;\n  * For Cohort B, FDG-PET\u002FCT scan for staging within 6 weeks prior to registration. For Cohort A, acceptable imaging for staging can include diagnostic CT neck\u002Fchest or PET-CT within 6 weeks prior to registration\n  * Zubrod Performance Status 0-1 within 4 weeks prior to registration;\n  * Age ≥ 18;\n  * Able to tolerate PET\u002FCT imaging required to be performed\n* For Cohort A, tumors must be potentially surgically resectable via a transoral approach, at the discretion of the treating surgeon. Additionally, they must have 0-2 clinically positive LNs on diagnostic CT or PET-CT according clinical consensus of the treatment team\n* For both cohorts, CBC required within 4 weeks prior to registration. For Cohort B, CBC\u002Fdifferential obtained within 4 weeks prior to registration on study, with adequate bone marrow function defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3;\n  * Platelets ≥ 100,000 cells\u002Fmm3;\n  * Hemoglobin ≥ 8.0 g\u002FdL\n* Serum creatinine within normal institutional limits or a creatinine clearance ≥ 45 ml\u002Fmin within 4 weeks prior to registration.\n* Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.\n* The patient must provide study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* cT4, cN3, or cM1 disease (also explained as AJCC 8th edition clinical staging,)\n* Patients with radiographic ECE or matted lymph nodes, defined as three nodes abutting one another with loss of intervening fat plane that is a replaced with radiologic evidence of extracapsular spread.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);\n* Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \\>3 years prior to study;\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;\n* Prior allergic reaction or hypersensitivity reactions to paclitaxel, carboplatin or other platinum containing products. This also includes patients with a history of severe hypersensitivity reaction to products containing Cremophor EL.\n* Severe, active co-morbidity, defined as follows:\n* Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n\n  * Transmural myocardial infarction within the last 3 months;\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;\n  * Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;\n  * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.\n  * Severe bone marrow depression or significant bleeding\n* Pregnancy or women of childbearing potential and men who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.\n* For Cohort B, poorly controlled diabetes (defined as fasting glucose level \\> 200 mg\u002FdL) despite 2 attempts to improve glucose control by fasting duration and adjustment of medications. Patients with diabetes will preferably be scheduled in the morning and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians.\n* Active enrollment on another clinical trial involving active treatment for the study cancer.",{"count":81,"type":20},150,[23],"Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation (+\u002F-chemo), or (2) individualized adaptive definitive chemoradiation (CRT).",[85,30],"Oropharyngeal Cancer","2026-01-30",{"date":88,"type":35},"2026-02-02",{"date":90,"type":35},"2023-04-27",{"date":92,"type":20},"2030-12",{"name":94,"class":42},"University of Michigan Rogel Cancer Center",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100520833","identification-of-individual-histological-and-blood-markers-in-patients-with-recurrent-or-metastatic-upper-aerodigestive-tract-squamous-cell-carcinoma-in-response-to-immunotherapies-100520833","NCT06061705","Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma in Response to Immunotherapies","iMonitORL","Inclusion Criteria:\n\n* Patients aged ≥ 18 years\n* Patients with histologically confirmed CEVADS involving the oral cavity, oropharynx, hypopharynx or larynx\n* Pre-treated patients with a first recurrence (locoregional or metastatic) who are candidates for immunotherapy\n* Patient affiliated to a health insurance plan\n* French-speaking patient\n* Patient with free, informed and written consent\n\nExclusion Criteria:\n\n* Patients with a contraindication to immunotherapy (transplant patients)\n* Pregnant or breast-feeding patients\n* Patient under guardianship or curatorship\n* Patient under court protection\n* Patient deprived of liberty",{"count":103,"type":20},100,[105],"NA","Epidermoid Carcinoma of the Upper Aerodigestive Tract (CEVADS) is the 6th most common cancer worldwide. Despite current therapies (radiotherapy, surgery and chemotherapy), cancers of the Upper Aerodigestive Tract (UAT) have a poor prognosis, with a 10-year survival rate of no more than 20%.\n\nFor recurrent or metastatic CEVADS, the therapeutic arsenal, based for many years on chemotherapy and anti-EGFR (Epidermal Growth Factor Receptor) agents, has been enriched by a new therapeutic class: PD-1 inhibitors. For CEVADS, PD-1 inhibitors have been approved for second-line treatment of nivolumab for over a year, and are now used in first-line treatment of pembrolizumab.\n\nThe results of this therapeutic class in CEVADS are not as spectacular as for melanoma or bronchial cancer. Indeed, only 20% of patients have a favorable response, compared with half who experience disease progression. This low proportion of responders can be explained by tumor heterogeneity within CEVADS and poor patient selection.\n\nThe only marker used to select patients is PD-L1 expression detected by ImmunoHistochemistry (IHC). However, it seems that this marker, described as imperfect, is still little explored in ENT. It needs to be compared with the expression of other cell lines in the tumor microenvironment, which could play an important role in resistance to PD-1 inhibitors.\n\nIHC identifies all macrophages using the CD68 marker, while the CD163 marker is specific to M2 macrophages.\n\nOther targets in the microenvironment are also being investigated, with the discovery of a Tertiary Lymphocyte Structure (TLS) in melanoma treated with immunotherapy.\n\nIt therefore seems necessary to gain a better understanding of the mechanisms of tumor progression under immunotherapy in order to develop strategies to optimize response to treatment. This would enable better selection of patients likely to benefit from immunotherapy, and open up prospects for therapeutic combinations.\n\nThe hypothesis is that macrophages, but also other cells and factors in the CEVADS microenvironment, play a decisive role in resistance to PD-1 inhibitors. The aim is therefore to continue these macrophage analyses, extend them to other cells in the microenvironment and link them to other prognostic factors under investigation.\n\nA prospective study will analyze tumor tissue during treatment with PD-1 inhibitors, in order to correlate all the factors studied with response or resistance to immunotherapies.\n\nIn addition, the oral microbiota, in the lineage of the intestinal microbiota, has been shown to be highly stable over time and to play a role in the oncogenesis of certain cancers, notably CEVADS. Like the intestinal microbiota, it could also represent a prognostic factor in the response to immunotherapies.\n\nOf all the bacteria in this oral microbiota, one has been shown to play a major role: Fusobacterium nucleatum (F. nucleatum). However, little is known about the mechanism of action of intratumoral F. nucleatum on the development of CEVADS. In particular, it is thought to play a role in local cancer immunity, via macrophages, regulatory T cells (Tregs) and TLRs. Finally, it appears that specific antimicrobial T-cell responses may cross-react with tumor antigens, hence the importance of also analyzing the metabolome of commensal bacteria.The aim of this study was to evaluate the evolution of the presence of this bacterium in saliva, as well as the specific immune response to F. nucleatum in patients with CEVADS during immunotherapy treatment.",[30],"2025-06-18",{"date":110,"type":35},"2025-06-24",{"date":112,"type":35},"2024-01-29",{"date":114,"type":20},"2026-06-30",{"name":116,"class":42},"Fondation Hôpital Saint-Joseph",3,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":128,"studyType":129,"phases":4,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100545344","head-and-neck-carcinoma-clinical-research-platform-for-molecular-and-blood-based-biomarkers-treatment-and-outcome-100545344","NCT06380686","Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome","Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based","HEAT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to understand and willing to sign written informed consent\n* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx)\n* Patients not amenable for curative treatment who receive palliative systemic treatment or best supportive care\n* Informed consent no later than four weeks after start of first-line palliative systemic treatment. For patients receiving \"best supportive care only\": no later than six weeks after diagnosis\u002Frecurrence or metastatic disease\n\nExclusion Criteria: none",{"count":127,"type":20},120,"36 Months","OBSERVATIONAL","Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent\u002Fmetastatic head and neck tumor patients.",[27,30,29,28],[133],"SCCHN","2024-11-11",{"date":136,"type":35},"2024-11-13",{"date":138,"type":35},"2024-11-07",{"date":140,"type":20},"2030-11",{"name":142,"class":42},"AIO-Studien-gGmbH",2,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":149,"conditions":155,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":43},"100370561","p16-oropharyngeal-cancer-radiation-optimization-trial-reducing-elective-treatment-volumes-protect-100370561","NCT04104945","p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)","Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study","PROTEcT","Inclusion Criteria:\n\n* Age 18 or older\n\n  * Provide informed consent\n  * ECOG performance status 0-2\n  * Histologically confirmed squamous cell carcinoma\n  * p16-positive tumor, as determined by immunohistochemistry at local hospital\n  * Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)\n  * Eligible for curative intent treatment.\n  * Smokers and non-smokers are included\n  * Tumor stage (AJCC 8th edition): T1 to T3\n  * Nodal stage (AJCC 8th edition): N1 to N2\n  * Adequate bone marrow function, hepatic, and renal function for chemotherapy (Hemoglobin \\> 80 g\u002FL; Absolute neutrophil count \\>1.5x109 \u002FL, platelets \\> 100 x109\u002FL; Bilirubin \\\u003C 35 umol\u002FL; AST or ALT \\\u003C 3 x the upper limit of normal; serum creatinine \\\u003C 130 umol\u002FL or creatinine clearance ≥ 50 ml\u002Fmin)\n\nExclusion Criteria:\n\n* \\- Clinical, radiologic or pathologic Ib nodal involvement (including invasion into submandibular gland)\n* Primary cancer with extension and involvement of the oral cavity\n* Metastatic disease\n* Contraindications to radiotherapy or chemotherapy\n* Prior history of head and neck cancer within 5 years\n* Prior head and neck radiation at any time\n* Inability to attend full course of radiotherapy or follow-up visits\n* Pregnant or lactating women",{"count":153,"type":20},32,[105],[30],"2024-03-01",{"date":158,"type":35},"2024-03-04",{"date":160,"type":35},"2021-01-12",{"date":162,"type":20},"2028-10-21",{"name":164,"class":42},"AHS Cancer Control Alberta",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":173,"conditions":174,"keywords":180,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":43},"100509828","observational-study-of-viral-biomarkers-and-micrornas-in-tumors-orofarynx-and-occult-tumors-positive-for-papilloma-virus-100509828","NCT05918510","Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus","Inclusion Criteria:\n\n* Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases laterocervical cytologically positive for squamous cell carcinoma treated with TORS or RT or RT\u002FCT\n* Age \\> 18 years\n* ECOG performance status \\\u003C\\_ 2\n* Ability to follow study procedures and complete questionnaires\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Presence of distant metastases at the time of diagnosis\n* Previous cancer of the head and neck district\n* Second tumor in therapy or follow-up for less than 5 years",{"count":172,"type":20},142,"Based on the evidence summarized in the introduction, the clinician hypothesize that the detection of the presence and expression of HPV-DNA, certain miRNAs, and a certain mutational profile in the tissues and biological fluids of these patients, may have important prognostic and diagnostic value not only in HPV-related OPSCCs but also in HPV+ occult T. Accordingly, this study aims to aim to better characterize their potential as biomarkers and to detect the possibility of their their use to implement the sensitivity and specificity of radiological methodologies (PET-CT and MRI), already in use in clinical practice, for monitoring disease progression in this specific subgroup. Finally, by using the collected material to generate organoids and Patient Derived Xenograft (PDX), the study also aims to identify possible new molecular drugs, which could solve the problem of resistance to radiochemotherapy.",[30,175,176,177,178,179],"Carcinomas of Unknown Primary Site","High-risk Human Papillomavirus Infection","Liquid Biopsy","Lymph Node Metastasis","Occult Tumor of the Head and Neck Area",[181,182,183,184],"Oropharyngeal Tumor","Occult Cancer","HPV Infection","head-neck area","2023-10-06",{"date":187,"type":35},"2023-10-10",{"date":189,"type":35},"2022-04-04",{"date":191,"type":20},"2029-04-04",{"name":193,"class":42},"Regina Elena Cancer Institute"]