[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-neck-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-neck-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,105,139,161,185,217,242],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100624131","stereotactic-mri-guided-focused-ultrasound-mesencephalotomy-100624131",false,"NCT07405645","Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy","Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy for Pain Palliation in Head, Neck, & Brachial Cancer","MRg-FUS","Inclusion Criteria:\n\n1. Men and women, between 18 and 85 years, inclusive\n2. Subjects with head, neck, or brachial cancer, including one of the following:\n\n   * Cancer that arises in the head and neck region: nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx (typically squamous cell carcinoma)\n   * Cancer occurring in the nasopharynx, skin, thyroid gland, and eye\n   * Cancer involving the brachial region including brachial plexus, upper lung apex, and Pancoast tumors.\n   * Lymphoma\n   * Sarcoma\n3. Craniofacial, cervical, or brachial pain related to the cancer that meets all of the following criteria:\n\n   * Severe defined by: Worst NPRS score of ≥ 5 out of 10 at current visit and the subject reports having a similar level of pain for at least the past two months.\n   * Pain is medication-refractory to all three tiers of the WHO cancer pain ladder. Thus, adequate trials of at least 3 prescription medications that will include a 'weak' and a 'strong' opioid. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect.\n   * Duration of greater than 3 months.\n4. Mesencephalon contralateral to the pain can be targeted by the ExAblate Neuro device. The region of the mesencephalon must be apparent on MRI. Additional MRI sequences including inversion-recovery and DTI may be utilized to refine the target.\n5. Subjects who are able and willing to give consent and able to attend all study visits\n6. Subjects who are able to communicate sensations during the focused ultrasound treatment\n\nExclusion Criteria:\n\n1. Idiopathic trigeminal neuralgia\n2. Trigeminal neuropathic pain from trauma, infection, or iatrogenic\n3. Post-herpetic neuralgia\n4. Headache syndromes like migraine, cluster headache\n5. Temporomandibular joint syndrome\n6. Atypical facial pain or pain related to a somatoform disorder\n7. Subjects deemed poor candidates by a multidisciplinary team of cancer and palliative care clinicians:\n\n   1. Subject deemed by their oncologist to have limited life expectancy for outcome assessment. At least 3 months life expectancy is required to obtain the primary efficacy outcome measure.\n   2. Significant clinician concern about reliability of subject-reported information, such as subject in active process of seeking disability for neuropathic pain\n   3. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-V as manifested by one (or more) of the following occurring within a 12 month period: Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household). Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)\n   4. Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)\n   5. Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).\n8. Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:\n\n   1. Exhibiting current suicide ideation and\u002For a history of suicide attempt within past 2 years\n   2. been hospitalized for the treatment of a psychiatric illness within the past 2 years\n   3. received transcranial magnetic stimulation for depression treatment\n   4. received electroconvulsive therapy for depression\n   5. any presence or history of psychosis\n9. Subjects with unstable cardiac status including:\n\n   1. Unstable angina pectoris on medication\n   2. Subjects with documented myocardial infarction within six months of protocol entry\n   3. Significant congestive heart failure defined with ejection fraction \\\u003C 40\n   4. Subjects with unstable ventricular arrhythmias\n   5. Subjects with atrial arrhythmias that are not rate-controlled\n10. Severe hypertension (diastolic BP \\> 100 on medication)\n11. Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.\n12. On medications that increases the bleeding risk, based on the published guidelines which are currently recognized by the American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine and the North American Neuromodulation Society (Reg Anesth Pain Med 2015;40: 182-212); specifically:\n\n    1. Aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abiciximab) for the last 7 days prior to treatment.\n    2. Oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours.\n    3. Intravenous or subcutaneous heparin-derived compounds for the last 48 hours.\n13. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.)\n14. Subjects participating or have participated in another pain management clinical trial in the last 30 days\n15. Subjects with risk factors for intraoperative or postoperative bleeding from a documented coagulopathy or if their serum coagulation studies (platelet count, PT, PTT, and INR) exceed the institutional laboratory limits.\n16. Subjects with brain tumors or any significant intracranial mass that impedes the acoustic beam. Subjects with cerebral metastasis may be included if the lesion(s) do not affect the FUS treatment.\n17. Any illness that in the investigator's opinion preclude participation in this study\n18. Pregnancy or lactation\n19. Legal incapacity or limited legal capacity\n20. Subjects with a deep brain stimulation implant\n21. Skull density ratio, calculated from the baseline noncontrasted head CT, is less than 0.4\n22. History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution\n23. Subjects whose primary pain is other than craniofacial or brachial neuropathic pain.\n24. Patients deemed high risk because of their airway for the procedure as evaluated by anesthesia.","ALL","18 Years","85 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","This phase 1 multi-site study investigates the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer and brachial cancer.",[28,29,30],"Head Neck Cancer","Squamous Cell Cancer of Head and Neck (SCCHN)","Cancer Pain",[32,33,34],"cancer pain","mesencephalotomy","focused ultrasound","RECRUITING","2026-02-04",{"date":38,"type":39},"2026-02-12","ACTUAL",{"date":41,"type":22},"2026-02-15",{"date":43,"type":22},"2029-12-31",{"name":45,"class":46},"University of Virginia","OTHER",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":73,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100572677","phase-1-intratumoral-delivery-of-viral-replicon-sarna-particles-expressing-il-12-in-head-and-neck-cancer-100572677","NCT06736379","Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer","Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer","Inclusion Criteria:\n\n1. Cohort A - Unresectable or recurrent\u002Fmetastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With one the following prior treatments:\n\n   Subjects must have received a platinum containing chemotherapy regimen, 5-Fluorouracil chemotherapy, taxane based chemotherapy, cetuximab or gemcitabine for treatment of primary tumor in locally advanced, or metastatic settings.\n\n   Subjects must have received an anti-PD-1\u002F PD-L1 as monotherapy or in combination with chemotherapy.\n\n   Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status).\n\n   Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).\n\n   Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, therefore these subjects must have been previously treated with an applicable tyrosine kinase inhibitor.\n\n   OR Cohort C - Patients with at least 1 measurable resectable lesion clinical stage I-IVb (cT1-4, N0-3) (AJCC, 8th Edition) (Amin, 2017), Histologically or cytologically confirmed HNSCC. Scheduled to undergo tumor surgical resection of the primary tumor.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function.\n3. Primary tumors should be amenable to intratumoral (IT) injection \\>1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved.\n4. Subjects with either a local recurrence or a new primary tumor will be allowed.\n5. Age ≥ 18 years.\n6. Have acceptable organ and marrow function defined as follows:\n\n   Absolute neutrophil count ≥ 1,500\u002FmcL Platelets ≥ 100,000\u002FmcL Hemoglobin ≥ 8.0 g\u002FdL (Note: use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002FdL is acceptable) Total bilirubin ≤2x institutional upper limit of normal (ULN) AST(SGOT) or ALT(SGPT) ≤ 3.0x institutional ULN\n7. Ability to understand and the willingness to provide written informed consent.\n8. Life expectancy \\> 12 weeks (about 3 months).\n9. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as determined by the Protocol Director or involved surgeon.\n2. Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study treatment and\u002For urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.\n3. Patients expected to receive other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) prior to surgery and where all acute toxicity of prior treatments have not resolved.\n4. Participation in another clinical study with an investigational product during the last 30 days.\n5. Uncontrolled intercurrent illness including, that do not respond to active medical intervention.\n6. Current or prior use of immunosuppressive medication within 28 days before the first dose of injection, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone or an equivalent corticosteroid.\n7. If applicable: Women who are breastfeeding.\n8. History of allogenic organ transplant that requires use of immunosuppressives.\n9. Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.\n10. Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n11. Uncontrolled intercurrent illness including those that do not respond to active medical intervention.\n12. Any contraindication to the use of known history of hypersensitivity to any immune therapy's drugs.",{"count":56,"type":22},41,[58],"PHASE1","The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are:\n\nThe safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01)\n\nThe tumor response to IT injections of VLPONC-01\n\nThe tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment\n\nResearchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.",[61,62,63,64,65,66,28,67,68,69,70,71,72],"Head and Neck Cancers- Squamous Cell","Head and Neck Cancer","Solid Tumors","HNSCC","SCC - Squamous Cell Carcinoma","SCCHN","Head and Neck Squamous Cell Cancer","Squamous Cell Carcinoma of the Head and Neck","Squamous Cell Carcinoma, Head And Neck","Squamous Cell Head and Neck Carcinoma","Oral Cavity","Oral Cavity Carcinoma",[74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"Virus-like particle","VLP","IL-12","Interleukin 12","Intratumoral","VRP","Viral Replicon Particle","saRNA","VRP-encapsulated","IT injection","pembrolizumab","anti-PD-1","tumor resection surgery","tumor resection","Self-amplifying RNA","Multiple inoculations directly into the tumor","Keytruda","viral particles per injection","viral particles","macrophage","2026-01-15",{"date":96,"type":39},"2026-01-20",{"date":98,"type":39},"2025-05-13",{"date":100,"type":22},"2027-12-30",{"name":102,"class":103},"VLP Therapeutics","INDUSTRY",1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100612544","phase-2-capecitabine-prior-to-tumor-resection-in-ent-oncology-capture-100612544","NCT07254962","CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)","CAPTURE","Inclusion Criteria:\n\n* • Previously untreated, histologically confirmed non-HPV related HNSCC and radiologically or histologically confirmed stage I or IVA (AJCC 8th edition).\n\n  * No evidence of distant metastatic disease.\n  * Able to undergo protocol therapy, including necessary imaging and surgery.\n  * If female: may participate if not actively pregnancy nor breastfeeding.\n  * If male: must agree to refrain from donating sperm and must either be abstinent or agree to use contraception.\n  * Performance status (ECOG) of 0, 1 or 2.\n\nExclusion Criteria:\n\n* History of immunodeficiency, HBV, HCV, HIV. No HBV, HCV or HIV testing is required unless mandated by local health authority.\n* Active infection requiring systemic therapy.\n* Previous allogenic tissue\u002Fsolid organ transplant.\n* Known severe hypersensitivity (≥ Grade 3) to capecitabine, its active substance and\u002For any of its excipients.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Known DYPD mutation.\n* Known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.\n* Received prior systemic anticancer therapy including investigational agents for the current malignancy prior to allocation.\n* Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.\n* Known additional malignancy that is progressing or requires active treatment within the past (5 years), excluding basal cell carcinoma or cutaneous squamous cell carcinoma.",{"count":113,"type":22},75,[115],"PHASE2","head and neck squamous cell carcinoma (HNSCC) is a type of cancer that affects areas such as the mouth, throat, and voice box. Despite medical progress, little has changed in the care for patients with HPV-negative cancer. The standard care involves surgery followed by radiation or chemotherapy if needed. However, delays in starting treatment - especially beyond six weeks - are linked to worse outcomes. Many patients also experience cancer returning within two years, often making it harder to treat. This study aims to improve outcomes by giving patients a short course of capecitabine, a chemotherapy pill, before surgery. Capecitabine is easier to tolerate than traditional intravenous chemotherapy and has shown promising results in shrinking tumors. Researchers believe that starting this oral treatment early could reduce delays, shrink tumors, make surgery less complex, and improve survival. The clinical trial will randomly assign patients with newly diagnosed stage III or IVa HPV-negative head and neck cancer to receive either standard care or capecitabine before surgery. Surgery will be performed within six weeks of diagnosis, followed by additional therapy as needed. The study will measure how well the tumor responds under the microscope after surgery, how much it shrinks on scans, the safety of the treatment, and cancer-free survival at two years. It will also explore biological markers linked to treatment response.\n\nIf successful, this approach could offer a simpler, faster, and more effective way to treat head and neck cancer, leading to earlier treatment, less invasive surgery, and improved patient outcomes. The study plans to include about 62 patients to evaluate the benefits of this new treatment strategy",[28,118,119,120,121],"Mouth Cancer","Throat Cancer","Larynx Cancer","Skin Cancer Face",[123,124,125,126,127,128],"window of opportunity","surgery","neoadjuvant","capecitabine","Head and neck cancer","HPV-negative","NOT_YET_RECRUITING","2025-11-19",{"date":132,"type":39},"2025-11-28",{"date":134,"type":22},"2026-01-01",{"date":136,"type":22},"2031-01-01",{"name":138,"class":46},"Sir Mortimer B. Davis - Jewish General Hospital",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":104},"100503705","phase-1-study-of-rimo-301-and-radiotherapy-with-pd-1-inhibitor-for-the-treatment-of-head-neck-cancer-100503705","NCT05838729","Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer","Phase 1b\u002F2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer","Inclusion Criteria:\n\n* Diagnosis of head-neck cancer that requires palliative radiotherapy\n* Patients with unresectable, recurrent or metastatic HNSCC, regardless if the patients have progressed on or are intolerant to platinum-based chemotherapy prior to study enrollment or if the patients are receiving pembrolizumab in the first line:\n\n  * receiving a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care, or\n  * suitable to receive a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care in the discretion of the treating physician or Principal Investigator\n* Must have at least 1 target lesion that is clinically accessible to RiMO-301 injection and amenable to receive RT regimens specified in this protocol\n* The selected target lesions must be measurable on cross-sectional imaging and repeated measurements at the same location should be achievable\n* Target tumor not in the previously irradiated field or in the field irradiated at least six months prior to RiMO-301 injection and with no complications from the prior radiation course\n* RiMO-301 injection to multiple lesions (≤ 5 in total) in a single patient is allowed as long as the total tumor volume does not exceed 250 cm3\n* Patient must have recovered from acute toxic effects (≤ grade 1 CTCAEv5) of previous cancer treatments prior to enrollment\n* Have adequate bone marrow reserve and adequate liver function\n* Have a life expectancy of at least 12 weeks\n* ECOG score of 0-2\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions\n* Symptomatic central nervous system metastases and\u002For carcinomatous meningitis\n* Active autoimmune disease that has required systemic treatment in the past 2 years\n* Ongoing clinically significant infection at or near the incident lesion\n* Major surgery over the target area (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days. No waiting is required following implantable port, enteral feeding tube and catheter placement\n* Has received any approved or investigational anti-neoplastic agent or immunotherapy other than PD-1 inhibitors (pembrolizumab or nivolumab) within 4 weeks prior to RiMO-301 injection\n* Patients with lesions which have significant blood vessel involvement (such as carotid artery encasement) or other major structures",{"count":147,"type":22},16,[58,115],"This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with hypofractionated radiation and a PD-1 Inhibitor in patients with unresectable, recurrent or metastatic head-neck cancer.",[28,151],"Intratumoral Injection","2025-09-11",{"date":154,"type":39},"2025-09-17",{"date":156,"type":39},"2023-04-03",{"date":158,"type":22},"2026-12",{"name":160,"class":103},"Coordination Pharmaceuticals, Inc.",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":169,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":104},"100565449","human-papillomavirus-association-and-genomic-exploration-in-head-neck-squamous-cell-carcinomas-100565449","NCT06642324","Human Papillomavirus Association and Genomic Exploration in Head-Neck Squamous Cell Carcinomas","Exploration of Human Papillomavirus Association and Genomic Characteristics in Head and Neck Squamous Cell Carcinomas in Bangladesh","HPV & HNSCC","Inclusion Criteria:\n\n1. Patient Age: adult (\\> 18 years)\n2. Head and neck squamous cell carcinoma diagnosed by biopsy (Histopathology confirmed HNSCC).\n3. Diagnosed cases specific Head-Neck sub-sites: (oral cavity, oropharynx, hypopharynx, larynx, tongue)\n4. Patient's Consent\n\nExclusion Criteria:\n\n1. Patient Age: children (\\\u003C 18 years)\n2. Cancers of any part of the body other than the head-neck region.\n3. People without HNSCC\n4. Any chronic diseases, genetic diseases, acute\u002Fchronic infectious diseases, etc. -",true,{"count":171,"type":22},550,"OBSERVATIONAL","Head and neck squamous cell carcinoma (HNSCC) represents a significant public health burden in Bangladesh with a high incidence and mortality rate. While traditional risk factors like tobacco and betel nut chewing contribute to HNSCC incidence, the emergence of HPV-associated HNSCC presents a unique challenge. The main goal of this observational study is to explore the prevalence, risk factors, and biological mechanisms underlying food habits and HPV-driven HNSCC in the population and identify the genomic changes and characteristics related to this malignancy. This study will provide the prevalence of HPV-associated HNSCC and screening the HPV typing in the Bangladeshi population, identify risk factors, and any biologically driven mechanisms causing HNSCC.",[28,175],"Oropharyngeal Neoplasms","2024-12-28",{"date":178,"type":39},"2024-12-31",{"date":180,"type":39},"2024-04-30",{"date":182,"type":22},"2025-09-30",{"name":184,"class":46},"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":195,"conditions":196,"keywords":204,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":104},"100506790","evaluation-of-skin-health-and-qol-in-pts-receiving-anti-pd1pdl1ctla4-or-cdk-inhibitors-100506790","NCT05878964","Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1\u002FPDL1\u002FCTLA4 or CDK Inhibitors.","Evaluation of Skin Health and Quality of Life in Patients Receiving Anticancer Therapies Based on Monoclonal Antibody Anti-PD1\u002FPDL1\u002FCTLA4 or Cyclin-dependent Kinase (CDK) Inhibitors","SkinHealth","Inclusion Criteria:\n\n(for all Groups)\n\n1. Age ≥ 18 years.\n2. Histological diagnosis of solid tumor.\n3. Patient able to complete the questionnaires submitted during the study.\n4. Signed written informed consent. (for Group I) Patients already under treatment for at least three months with anti-PD1\u002FPDL1\u002F CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor.\n\n(for Group II) Patients eligible for treatment with anti-PD1\u002FPDL1\u002F CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor.\n\nExclusion Criteria (for all Groups):\n\n1. Age \\\u003C 18 y.o.\n2. Skin diseases or alterations present before the beginning of anti-PD1\u002FPDL1 or cyclin-dependent kinase (CDK) inhibitors.\n3. Chronic use of steroids.\n4. Previous psychiatric disorders or patients taking antidepressant.\n5. Refusal to sign written informed consent.",{"count":194,"type":22},420,"The study aim to investigate the relationship between cutaneous adverse events and quality of life in patients taking immune check point inhibitor or cyclin-dependent kinase (CDK) 4 and 6 inhibitors by two steps. In the first one, it will be investigated the relationship between the skin toxicity related to the use selected therapies and the quality of life of patients already receiving these therapies for treatment of their cancer. In the second one, it will be evaluated the relationship between skin toxicity and quality of life over three months of treatment in patients initially naïve for selected therapies. Cancer included in the analysis are NSCLC, renal cancer, gastric cancer, breast cancer, bladder cancer, melanoma, squamous cell carcinoma of the head and neck.",[197,198,199,200,201,202,203,28],"Lung Cancer","Breast Cancer","Kidney Cancer","Bladder Cancer","Gastric Cancer","Skin Cancer","Melanoma",[205,206,207],"immunotherapy","cyclin-dependent kinase (CDK) inhibitors","cutaneous toxicity","2024-10-03",{"date":210,"type":39},"2024-10-04",{"date":212,"type":39},"2023-05-22",{"date":214,"type":22},"2025-09-22",{"name":216,"class":46},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":104},"100468653","newer-therapeutic-targets-in-head-and-neck-cancers-100468653","NCT05382585","Newer Therapeutic Targets in Head and Neck Cancers","A Cohort Study to Identify Newer Therapeutic Targets in Head and Neck Cancers","Inclusion Criteria:\n\n* Histologically proven cases of primary head and neck cancers.\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Pregnant and lactating women\n* Multiple cancers or patients with cancer of other sites.","100 Years",{"count":226,"type":22},200,"Based on the recently identified mutations in HNSCCs, the major pathologic pathways implicated in the tumorigenesis of HNSCC include dysregulation of four processes:\n\n1. cellular survival and proliferation (e.g., TP53, EGFR, MET, and PIK3CA);\n2. cell-cycle control (e.g., CDKN2A and CCND1);\n3. cellular differentiation (e.g., NOTCH1); and\n4. Adhesion and invasion signaling (e.g., FAT1).7 TP53, EGFR, PIK3CA, CDKN2A, CCND1, and MET participate in several common signaling pathways.\n\nAlterations of these genes are most frequently seen in alcohol and tobacco-related HNSCC. However their role in prognostication and selection of therapeutics is not known",[28,229],"Oral Cancer",[231,232],"Next generation sequencing","predictive biomarker","2024-08-09",{"date":235,"type":39},"2024-08-13",{"date":237,"type":39},"2017-04-01",{"date":239,"type":22},"2027-12-31",{"name":241,"class":46},"Banaras Hindu University",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":104},"100556854","phase-2-pretreatment-botulinum-toxin-in-head-and-neck-cancer-surgery-100556854","NCT06530524","Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery","Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer","Inclusion Criteria:\n\n* Newly diagnosis AJCC 8th edition Stage III\u002FIVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy).\n\nExclusion Criteria:\n\n* Previous radiation to the head and neck\n* Previous treatment for head and neck cancer\n* Personal history of xerostomia\n* Hypersensitivity to onabotulinumtoxinA\n* Previous major salivary gland surgery\n* Previous exposure to radioactive iodine therapy",{"count":250,"type":22},50,[115],"Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.",[28,254],"Xerostomia Following Radiotherapy",[62,256,257,258],"Radiation induce xerostoma","botulinum toxin","salivary glands","2024-07-26",{"date":261,"type":39},"2024-07-31",{"date":263,"type":22},"2024-10-01",{"date":265,"type":22},"2027-12-01",{"name":138,"class":46}]