[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-cancer-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-cancer-patients":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,68,87,113,136,157,172,196],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100614569","mindfulness-oriented-respiratory-distress-symptom-intervention-for-lung-cancer-100614569",false,"NCT07281300","Mindfulness-Oriented Respiratory Distress Symptom Intervention for Lung Cancer","Mindfulness-Oriented Respiratory Distress Symptom Intervention for Patients With Lung Cancer: A Feasibility Randomized Controlled Trial","Inclusion Criteria:\n\n* HK patients who can understand Cantonese, aged 18 years or older;\n* A confirmed diagnosis of an intrathoracic malignancy, including small cell lung cancer, non-small cell lung cancer, or mesothelioma; at any stage of cancer treatment or palliative care;\n* Self-reported impact on daily life from at least two of the three symptoms, where one symptom is breathlessness;\n* Stability of COPD, if present;\n* WHO Performance Status of 0-2;\n* fMRI can be conducted;\n* Expected lifespan of more than six months.\n\nExclusion Criteria:\n\n* Cognitive impairments, severe psychotic symptoms, or other medical conditions that might hinder participation;\n* Participating in mindfulness or other psychological support interventions or symptom management interventions.",true,"ALL","18 Years",{"count":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"NA","Lung cancer is the leading cause of cancer mortality, posing a critical public health challenge in both Hong Kong and global populations. Patients with lung cancer frequently experience a distressing symptom cluster characterized by breathlessness-driven respiratory distress, accompanied by persistent cough and fatigue, which collectively impose a substantial disease burden. While our research team leader previously developed and validated a multi-component Respiratory Distress Symptom Intervention (RDSI) in England, demonstrating clinical efficacy for lung cancer management, its impact on psychological distress (anxiety and depression) proved limited. This limitation may reflect insufficient integration of psychological components, a crucial consideration given the well-established bidirectional relationship between respiratory symptoms and psychological distress. Emerging evidence indicates that mindfulness interventions provide dual therapeutic benefits by improving patient adherence and effectively addressing both physical symptoms, such as breathlessness and fatigue, as well as psychological distress, including anxiety and depression. Meanwhile, current evaluation methodologies have mainly focused on behavioral data collection, such as self-reported questionnaires, to reflect the effect before and after the intervention. Neuroimaging data can help understand the brain mechanisms underlying breathlessness and elucidate the effectiveness of interventions, thereby improving intervention strategies.",[27,28,29,30,31,32],"Symptom Cluster","Breathlessness","Coughing","Fatigue Symptom","Lung Cancer Patients","Brain Activity","RECRUITING","2026-04-14",{"date":36,"type":37},"2026-04-17","ACTUAL",{"date":39,"type":37},"2025-08-12",{"date":41,"type":21},"2027-07-30",{"name":43,"class":44},"The Hong Kong Polytechnic University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":45},"100601627","press-needle-acupuncture-for-pain-and-quality-of-life-in-lung-cancer-patients-100601627","NCT07112950","Press Needle Acupuncture for Pain and Quality of Life in Lung Cancer Patients","The Effect of Press Needle Acupuncture on Pain Reduction and Quality of Life Improvement in Lung Cancer Patients","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of lung cancer through histopathology or radiology.\n* Lung cancer patients aged over 18 years.\n* Stage III-IV lung cancer patients receiving therapy at Dr. Cipto Mangunkusumo National General Hospital (RSUPN) and Tangerang District General Hospital (RSUD Kabupaten Tangerang).\n* Patients with a VAS score \\>10 mm for baseline pain and \\>40 mm during breakthrough pain.\n* Willing to participate in the study until completion by signing the informed consent form.\n\nExclusion Criteria:\n\n* Lung cancer patients with deteriorating general condition.\n* Presence of wounds or infections at the press needle insertion site.\n* History of allergy to stainless steel materials.\n* Patients with blood clotting disorders: platelet count \\\u003C50,000\u002FμL, ANC \\\u003C1000\u002Fmm³, or patients undergoing anticoagulant therapy with INR \\>2.142.",{"count":54,"type":21},32,[24],"The purpose of this clinical trial is to evaluate the effect of press needle acupuncture on pain management and quality of life improvement in patients with lung cancer.\n\nThe main question this study aims to answer is:\n\nDoes press needle acupuncture, when combined with standard therapy, provide better pain relief and quality of life improvement in lung cancer patients compared to standard therapy alone?\n\nResearchers will compare press needle acupuncture to sham acupuncture to determine whether press needle acupuncture is more effective in reducing pain and improving quality of life.\n\nParticipants will:\n\nReceive either press needle acupuncture or sham press needle acupuncture for 7 days\n\nVisit the clinic once a week for examination and evaluation\n\nRecord improvements in pain intensity in a pain diary and assess quality of life using a quality of life questionnaire",[31],"NOT_YET_RECRUITING","2025-08-01",{"date":61,"type":37},"2025-08-08",{"date":63,"type":21},"2025-08-11",{"date":65,"type":21},"2025-12-01",{"name":67,"class":44},"Indonesia University",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100598500","deb-bace-for-primary-lung-cancer-a-retrospective-single-arm-multicenter-study-on-efficacy-and-safety-100598500","NCT07072299","DEB-BACE for Primary Lung Cancer: A Retrospective, Single-Arm, Multicenter Study on Efficacy and Safety","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old, gender unrestricted; 2. Diagnosed with primary lung cancer based on the Primary Lung Cancer Diagnosis and Treatment Guidelines (2022 Edition) through histopathological examination; 3. At least one measurable lesion (evaluated according to RECIST 1.1 criteria); 4. Previously received at least one DEB-BACE treatment; 5. ECOG PS score ≤ 2; 6. Complete patient case records.\n\nExclusion Criteria:\n\n* 1\\. Presence of extensive and uncontrolled extrapulmonary brain metastasis lesions; 2. Irreversible coagulation dysfunction within a short period of time; 3. Uncontrollable hypertension, diabetes, or significant cardiovascular diseases with obvious symptoms; 4. Allergy to contrast agent; 5. Pregnant or lactating women; 6. Patients whose condition, as judged by the investigator, poses a serious threat to patient safety or hinders their participation in the study.",{"count":75,"type":21},1213,"OBSERVATIONAL","This is a retrospective, single-arm, multicenter clinical study designed to evaluate the efficacy and safety of DEB-BACE (Drug-Eluting Bead Bronchial Artery Chemoembolization) in the treatment of primary lung cancer.",[31],"2025-07-17",{"date":81,"type":37},"2025-07-18",{"date":59,"type":21},{"date":84,"type":21},"2026-08-01",{"name":86,"class":44},"Gang Wu, MD",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":45},"100594821","tubeless-anesthesia-in-preventing-lung-complications-in-patients-undergoing-surgery-for-early-stage-lung-cancer-100594821","NCT07024433","Tubeless Anesthesia in Preventing Lung Complications in Patients Undergoing Surgery for Early-Stage Lung Cancer","Tubeless Anesthesia in Preventing Contralateral Lung Complications in Patients Undergoing Single-Port Thoracoscopic Surgery for Early-Stage Lung Cancer: A Single-Center, Prospective, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥18 years and ≤70 years;\n2. ECOG performance status score 0-1;\n3. Good cardiac and pulmonary function;\n4. Single or multiple peripheral lung nodules planned for single-port thoracoscopic surgery, with or without mediastinal lymph node dissection or sampling;\n5. Able to comply with the study visit schedule and other protocol requirements;\n6. Signed informed consent and voluntary participation in the study.\n\nExclusion Criteria:\n\n1. Obese patients (BMI \\>30);\n2. Patients with difficult intubation or expected complex airway management;\n3. COPD patients with copious airway secretions;\n4. Patients with neurological dysfunction or who cannot cooperate while awake;\n5. Patients expected to have extensive pleural adhesions or with previous lung resection;\n6. Elderly and frail patients with severe hypoxia (PaO2 \\\u003C60 mmHg) or hypercapnia (PaCO2 \\>50\u002F55 mmHg);\n7. Previous induction chemotherapy or chemoradiotherapy;\n8. Intraoperative need to isolate the lung to prevent spillage and contamination of the contralateral lung;\n9. Patients expected to have large surgical wounds and lengthy procedures, clinically assessed as unsuitable;\n10. Patients whose cardiac and pulmonary function, or overall health, cannot withstand the procedure.","70 Years",{"count":96,"type":21},224,[24],"The study focuses on evaluating the effectiveness and safety of tubeless anesthesia in single-port thoracoscopic surgery for early-stage lung cancer patients. Traditional anesthesia methods risk postoperative complications like lung injury and respiratory issues. Tubeless anesthesia preserves spontaneous breathing without tracheal intubation, potentially reducing these complications and enhancing recovery. The study aims to compare this technique with traditional methods, assessing its impact on contralateral lung complications, perioperative hemodynamics, complication rates, and recovery speed.",[31],[101,102,103],"Early-stage lung cancer","Tubeless anesthesia","Single-port thoracoscopic surgery","2025-06-09",{"date":106,"type":37},"2025-06-17",{"date":108,"type":37},"2025-05-25",{"date":110,"type":21},"2027-12-03",{"name":112,"class":44},"Fujian Medical University Union Hospital",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":122,"studyType":76,"phases":4,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":45},"100575648","sers-based-serum-molecular-spectral-detection-of-invasive-lung-cancer-100575648","NCT06775015","SERS-Based Serum Molecular Spectral Detection of Invasive Lung Cancer","SERS-Based Serum Molecular Spectral Detection of Lung Cancer Microinvasion Versus Invasion Screening: A Multicenter, Open-Label, Double-Blind, Independent Data Analysis Clinical Trial","Inclusion Criteria:\n\n1. Participants confirmed by chest CT to have pulmonary nodules\n2. The diagnosis of participants with malignant pulmonary nodules must meet the TNM diagnostic criteria (Ninth Edition);\n3. Participants are willing to participate in this study and follow the research plan;\n4. Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website;\n\nExclusion Criteria:\n\n1. Participants with concomitant other malignant tumors;\n2. Participants with missing baseline clinical data;\n3. Participants with severe underlying lung diseases (such as bronchiectasis, bronchial asthma or COPD, etc.), or those with a history of occupational or environmental exposure to dust, mines or asbestos;\n4. Participants who do not cooperate or refuse to participate in clinical trials at a later stage.",{"count":121,"type":21},200,"1 Year","Surgery is the main treatment for early lung cancer. It is worth noting that there are significant differences in postoperative prognosis and surgical methods between microinvasive cancer and early-stage invasive cancer. Micro invasive lung cancer can achieve 100% long-term survival through surgical resection, without the need for postoperative adjuvant radiotherapy. There is no need to remove lung lobes during surgery, only segmental or wedge resection is required, and systematic lymph node dissection is not recommended. Therefore, accurate prediction of preoperative and intraoperative microinvasive cancer and invasive cancer in pulmonary nodules is crucial for patients to choose surgical methods, which can significantly affect postoperative lung function retention and overall survival.\n\nRaman spectroscopy (RS), as a non-invasive and highly specific molecular detection technique, can be obtained at the molecular level to sensitively detect changes in biomolecules composed of proteins, nucleic acids, lipids, and sugars related to tumor metabolism in biological samples. The surface enhanced Raman spectroscopy (SERS) developed based on this technology is one of the feasible methods for high-sensitivity biomolecule analysis.\n\nWe collected serum Raman spectroscopy data from a cohort of 138 early lung cancer patients in our preliminary research. Based on a machine learning model, we constructed an early lung microinvasive cancer and invasive cancer Raman intelligent diagnosis system, which achieved an accuracy rate of 89.4%. To obtain the highest level of clinical evidence and truly achieve clinical translation, this prospective, multicenter clinical study aims to validate the use of this intelligent diagnostic system for early diagnosis of lung cancer and the discrimination between microinvasive cancer and invasive cancer.",[31],[126],"SERS，Raman，Early screening for lung cancer，Pulmonary nodule，diagnostic model","2025-03-26",{"date":129,"type":37},"2025-03-31",{"date":131,"type":21},"2026-04-04",{"date":133,"type":21},"2026-12-31",{"name":135,"class":44},"Fuzhou General Hospital",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100580104","efficacy-and-safety-of-cryoablation-with-robotic-bronchoscopy-system-in-patients-with-lung-cancer-100580104","NCT06832956","Efficacy and Safety of Cryoablation with Robotic Bronchoscopy System in Patients with Lung Cancer","Inclusion Criteria:\n\n* (1) Age ≥ 18 years old, regardless of gender. (2) Diagnosed with peripheral lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number of tumors ≤ 3. (3) The lesion to be ablated is evaluated as suitable for bronchoscopy-guided cryoablation treatment. (4) The subject refuses or is deemed unsuitable for radiotherapy\u002Fchemotherapy, or shows no response to previous radiotherapy\u002Fchemotherapy, or experiences disease progression after radiotherapy\u002Fchemotherapy. (5) Assessed as ineligible for surgery or refuses surgery and radiotherapy, consents to receive initial ablation treatment, and signs the informed consent form.\n\nExclusion Criteria:\n\n* (1) Diffuse lesions in both lungs where ablation treatment is unlikely to improve the condition. (2) Presence of hilar lymph node metastasis or extrapulmonary metastasis as indicated by examinations within 1 month before the operation (except for extrapulmonary metastasis that has been controlled by local treatment). (3) Presence of contraindications for bronchoscopy, or inability to tolerate or cooperate with bronchoscopy. (4) Severe bleeding tendency, uncorrectable coagulation dysfunction (prothrombin time \\> 18 s, prothrombin activity \\\u003C 40%). (5) Platelet count \\\u003C 70×109\u002FL, or anticoagulant and\u002For antiplatelet drugs have not been discontinued for more than 1 week before ablation (except for prophylactic use of low-molecular-weight heparin before the operation). (6) Severe impairment of lung function, with maximum ventilation \\\u003C 40%. (7) Concurrent with other tumors and extensive metastasis, with an expected survival period of less than 3 months. (8) Poor general condition (multiple metastases throughout the body, severe infection, high fever), infectious and radiation-induced inflammation around the lesion, obvious cachexia, severe insufficiency of vital organs, severe anemia and nutritional metabolic disorders that cannot be improved in the short term. (9) Eastern Cooperative Oncology Group (ECOG) performance status score \\> 2. (10) The lesion to be ablated has received radiotherapy within the past 6 months. (11) Presence of active hepatitis B, active hepatitis C, history of human immunodeficiency virus (HIV) infection (known positive for HIV 1\u002F2 antibodies), or other active infections that may affect the patient's treatment as judged by the investigator. (12) Accompanied by epilepsy, history of mental illness or cognitive impairment. (13) Pregnant or lactating women, and male or female patients planning to conceive or become pregnant during the trial. (14) Participation in any other clinical trial within 3 months before signing the informed consent form (except for non-interventional studies). (15) Other circumstances considered inappropriate for participation in this clinical trial by the investigator.","75 Years",{"count":144,"type":21},10,[24],"The goal of this single-arm clinical trial is to evaluate the safety and efficacy of robotic bronchoscopy system (RBS)-assisted cryoablation in the treatment of primary lung cancer in adult patients (aged ≥18 years) with histologically confirmed non-resectable primary lung cancer, regardless of gender. The main questions it aims to answer are:\n\nDoes RBS-assisted cryoablation achieve a predefined target technical success rate for complete tumor ablation under imaging guidance? Is the incidence of severe procedure-related adverse events within an acceptable safety threshold ?\n\nParticipants will:\n\nProvide written informed consent for RBS-assisted cryoablation.\n\nUndergo pretreatment evaluations, including:\n\nMultimodal imaging (CT\u002FPET-CT) for tumor localization and staging. Pulmonary function tests and cardiopulmonary risk assessment. Receive RBS-guided cryoablation therapy under general anesthesia. Be monitored for intraoperative complications and postoperative adverse events for 72 hours.\n\nComplete follow-up assessments at 1, 3, 6, and 12 months post-procedure, including:\n\nContrast-enhanced CT scans to evaluate local tumor control. Documentation of symptom progression and quality-of-life metrics.",[31],"2025-02-12",{"date":150,"type":37},"2025-02-18",{"date":152,"type":21},"2025-02-15",{"date":154,"type":21},"2025-12-31",{"name":156,"class":44},"Guangzhou Medical University",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":170,"leadSponsor":171,"locationsCount":4},"100580105","a-clinical-study-of-the-cryoablation-technique-for-peripheral-lung-malignancies-100580105","NCT06832969","A Clinical Study of the Cryoablation Technique for Peripheral Lung Malignancies","A Clinical Study on Verifying the Cryoablation Technique for Peripheral Lung Malignancies Under Bronchoscopy Guidance","Inclusion Criteria:\n\n* (1) Age ≥ 18 years, with no gender restrictions; (2) Diagnosed as having peripheral lung cancer, with the maximum diameter of the tumor being ≤ 3 cm and the number of tumors being ≤ 3; (3) The lesion intended for ablation is evaluated as feasible for bronchoscopy-guided cryoablation therapy; (4) The subject refuses or is deemed unsuitable for radiotherapy\u002Fchemotherapy, or has no response to previous radiotherapy\u002Fchemotherapy, or has disease progression after radiotherapy\u002Fchemotherapy; (5) Assessed as ineligible for surgery or refuses surgery and radiotherapy, consents to receive initial ablation treatment and signs the informed consent form.\n\nExclusion Criteria:\n\n* (1) Diffuse lesions in both lungs where ablation therapy fails to improve the condition; (2) Examinations within one month prior to the operation reveal the presence of hilar lymph node metastasis or extrapulmonary metastasis (except for cases where extrapulmonary metastasis has been controlled through local treatment); (3) Existence of contraindications for bronchoscopy, or inability of the patient to tolerate or cooperate with bronchoscopy; (4) Severe bleeding tendencies or uncorrectable coagulation dysfunctions (prothrombin time \\> 18 seconds, prothrombin activity \\\u003C 40%); (5) Platelet count \\\u003C 70×109\u002FL, or discontinuation of anticoagulant and\u002For antiplatelet drugs less than one week before ablation (except for the prophylactic use of low-molecular-weight heparin before the operation); (6) Severe impairment of lung function with a maximum ventilation volume \\\u003C 40%; (7) Concurrent presence of other tumors with extensive metastasis and an expected survival period of less than 3 months; (8) Poor overall condition (multiple metastases throughout the body, severe infection, high fever), infectious and radiation-induced inflammation around the lesion, obvious cachexia, severe dysfunction of important organs, severe anemia and short-term uncorrectable nutritional and metabolic disorders; (9) Eastern Cooperative Oncology Group (ECOG) performance status score \\> 2; (10) The lesion to be ablated has received radiotherapy within the past 6 months; (11) Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) infection history (known positive for HIV1\u002F2 antibodies), or other active infections that are judged by the researcher to potentially affect the patient's treatment; (12) Accompanied by epilepsy, history of mental illness or cognitive impairment; (13) Pregnant or lactating women, as well as male or female patients who plan to have children or become pregnant during the trial; (14) Participation in any other clinical trials within 3 months before signing the informed consent (excluding non-interventional studies); (15) Other circumstances deemed by the researcher as inappropriate for participation in this clinical trial.",{"count":144,"type":21},[24],"To assess the safety and effectiveness of bronchoscopy-guided cryoablation with cold verification for peripheral lung malignancies.",[31],{"date":150,"type":37},{"date":152,"type":21},{"date":154,"type":21},{"name":156,"class":44},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":4},"100571820","machine-learning-for-predicting-and-managing-quality-of-life-in-lung-cancer-immunotherapy-patients-100571820","NCT06725225","Machine Learning for Predicting and Managing Quality of Life in Lung Cancer Immunotherapy Patients","Development of a Machine Learning-Based Risk Prediction Model and Stratified Management Strategies for Quality of Life in Lung Cancer Patients Undergoing Immunotherapy","Inclusion Criteria:\n\n1. Histologically diagnosed with lung cancer\n2. Age over 18 years\n3. Currently receiving immunotherapy for lung cancer\n4. Good verbal communication ability\n5. Informed consent signed by the patient or family member\n\nExclusion Criteria:\n\n1. Cognitive impairment or mental illness\n2. Other severe diseases",{"count":121,"type":21},[24],"The goal of this study is to explore whether health-related quality of life (HRQoL) can be used as a predictive indicator for lung cancer patients and to implement clinical interventions. The study addresses two main objectives:\n\nAnalyzing HRQoL data of lung cancer patients undergoing immunotherapy using machine learning clustering methods to explore data patterns and build an HRQoL early warning model (already developed).\n\nValidating this HRQoL early warning model in real-world settings by classifying patients with different HRQoL characteristics and assessing the clinical value of the model",[31],[184,185,186],"HRQOL","lung cancer","immunotherapy","2024-12-09",{"date":189,"type":37},"2024-12-13",{"date":191,"type":21},"2025-01-01",{"date":193,"type":21},"2026-04-01",{"name":195,"class":44},"Second Affiliated Hospital of Zunyi Medical University",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":45},"100541560","phase-2-treatment-of-pulmonary-sulcus-pancoast-and-chest-wall-non-small-cell-lung-cancer-employing-radiation-immuno-oncology-and-resection-100541560","NCT06331455","Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection","Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer","SUPER","Inclusion Criteria:\n\n1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n2. Age \\> 18 years at time of study entry.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n4. Body weight \\>30 kg\n5. Adequate normal organ and marrow function as defined below Hemoglobin ≥9.0 g\u002FdL Absolute neutrophil count (ANC) ≥1.0 × 10\\^9\u002FL Platelet count ≥75 × 10\\^9\u002FL Serum bilirubin in normal range with the exception of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional upper limit of normal\n\n   Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\n   Males:\n\n   Creatinine CL (mL\u002Fmin)=Weight (kg) x (140 - Age) \u002F 72 x serum creatinine (mg\u002FdL)\n\n   Females:\n\n   Creatinine CL (mL\u002Fmin)=Weight (kg) x (140 - Age) x 0.85 \u002F 72 x serum creatinine (mg\u002FdL)\n6. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n7. Must have a life expectancy of at least 12 weeks\n8. Tumor amenable to biopsy\n9. Patients with NSCLC stage IIB to IIIB.\n10. PD-L1 positive tumors defined by tumor proportion score (TPS) \\>1%\n11. Patient suitable for surgery and combined modality therapy in the opinion of the investigator.\n12. Complete R0 resection of the primary tumor and involved lymph nodes is anticipated based on the clinical staging and radiological evaluation according to the baseline pre-treatment imaging.\n\nExclusion Criteria:\n\n1. Participation in another clinical study with an investigational product during the last 8 weeks before enrollment\n2. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n3. Known oncogenic driver mutations such as EGFR mutant or ALK mutant\n4. The presence of N3 disease in the contralateral mediastinum, contralateral hilum, or contralateral supraclavicular lymph node confirmed histologically.\n5. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Sponsor.\n\n   Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the StudySponsor.\n6. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n7. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.\n8. History of allogenic organ transplantation.\n9. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n   Patients with vitiligo or alopecia Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement Any chronic skin condition that does not require systemic therapy Patients without active disease in the last 5 years may be included but only after consultation with the Study Sponsor Patients with celiac disease controlled by diet alone\n10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n11. History of another primary malignancy except for:\n\n    Malignancy treated with curative intent that does not require treatment, nor anticipated to require treatment for the duration of the study, and in the opinion of the investigator would not pose a risk of increased toxicity, or difficulty to follow the protocol and assess study endpoints Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease\n12. History of leptomeningeal carcinomatosis, malignant pleural effusion or distant metastasis (M1)\n13. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry\n14. History of active primary immunodeficiency\n15. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n16. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n17. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n18. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n19. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n20. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n21. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n22. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4:\n\n    Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n\n    All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n\n    Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE:\n\n    Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n\n    Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.\n23. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.","99 Years",{"count":206,"type":21},12,[208],"PHASE2","The SUPER trial is a prospective Phase II trial. It is designed for patients with stage 2 or 3 non-small cell lung cancer (NSCLC) prior to surgery.\n\nPatients who are enrolled in this trial will receive combination of Non-ablative oligofractionated radiation (NORT) and two cycles of Durvalumab, an immunotherapy drug before their surgery.",[31,211],"Non-small Cell Lung Cancer (NSCLC)","2024-07-18",{"date":214,"type":37},"2024-07-22",{"date":216,"type":37},"2024-05-22",{"date":218,"type":21},"2026-04",{"name":220,"class":44},"Marc de Perrot"]