[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618959":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":41,"studyPopulation":44,"armGroups":45,"interventions":55,"overallOfficials":41,"centralContacts":61,"locations":70,"responsibleParty":161,"collaborators":163,"id":172,"slug":41,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":41,"eligibilityCriteria":177,"healthyVolunteers":173,"sex":178,"minAge":179,"maxAge":41,"enrollmentInfo":180,"targetDuration":183,"studyType":184,"phases":41,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":191,"whyStopped":41,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"Guangzhou University of Traditional Chinese Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":36},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival","Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.","From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.",{"measure":14,"description":15,"timeFrame":16},"Disease-Free Survival","From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, whichever occurs first.","From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, assessed up to 5 years.",[18,22,25,29,33],{"measure":19,"description":20,"timeFrame":21},"Objective Response Rate","Objective response rate is defined as the proportion of patients achieving complete (CR) or partial (PR) response according to RECIST V.1.1 criteria.","Through study completion, an average of 3 years.",{"measure":23,"description":24,"timeFrame":21},"Disease Control Rate","Disease control rate is determined by the percentage of patients who achieve CR, PR, or SD as defined by RECIST V.1.1 criteria. This encompasses all instances of CR, PR, and SD (CR + PR + SD).",{"measure":26,"description":27,"timeFrame":28},"Overall Survival","Overall survival is defined as the time until death due to any cause.","From the date of randomization until the date of death from any cause, assessed up to 5 years.",{"measure":30,"description":31,"timeFrame":32},"Quality of life evaluation","According to the requirements of European Organisation for Research and Treatment of Cancer-quality of life core questionnaire (EORTC QLQ-C30)\u002FLung cancer 29 items (LC 29), the scoring results of each field of the scale were recorded in CRF. The score of this questionnaire ranges between 1 and 4. The higher score indicates the worse quality of life.","At the baseline, every 3 months until disease recurrence\u002Fprogression or the end of the study, assessed up to 3 years.",{"measure":34,"description":35,"timeFrame":32},"Traditional Chinese Medicine Symptom Assessment","According to the requirements of the MDASI-TCM scale, the scores of each domain were recorded in the CRF. Each item is rated on a numeric scale ranging from 0 to 10, with higher scores indicating greater symptom severity or symptom interference.",[37],{"measure":38,"description":39,"timeFrame":32},"Traditional Chinese Medicine (TCM) Syndrome Classification","Tongue and pulse characteristics will be collected using standardized and validated tongue diagnosis and pulse diagnosis devices. Standardized symptom information (e.g., fatigue, poor appetite) will be collected by licensed TCM practitioners. Symptoms will be recorded as present or absent without severity grading. Based on tongue, pulse, and symptom information, TCM practitioners will determine and classify each participant's TCM syndrome pattern (e.g., cold syndrome, heat syndrome) at each assessment time point.",{"allocation":41,"interventionModel":41,"interventionModelDescription":41,"primaryPurpose":41,"observationalModel":42,"timePerspective":43,"maskingInfo":41},null,"COHORT","PROSPECTIVE","This study will enroll approximately 3000 adult patients with EGFR-mutant non-small cell lung cancer (NSCLC) who are initiating standard EGFR-TKI therapy.",[46,51],{"label":47,"type":41,"description":48,"interventionNames":49},"Advanced Cohort","Participants in this cohort are patients with stage IIIb-IV non-small cell lung cancer (NSCLC) harboring an EGFR sensitizing mutation, who are receiving or are planned to receive first-line EGFR-TKI therapy within 2 weeks as their first-line treatment.",[50],"Drug: EGFR-TKI",{"label":52,"type":41,"description":53,"interventionNames":54},"Postoperative Cohort","Participants in this cohort are patients who have undergone complete surgical resection (R0) for NSCLC with an EGFR sensitizing mutation and who are receiving or are planned to receive adjuvant EGFR-TKI therapy within 2 weeks as their postoperative treatment.",[50],[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":41},"DRUG","EGFR-TKI","Standard treatment with EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, osimertinib) for NSCLC. The study observes its association with TCM syndrome patterns.",[47,52],[62,67],{"name":63,"role":64,"phone":65,"phoneExt":41,"email":66},"Lina Ding","CONTACT","86-020-81887233","2804138491@qq.com",{"name":68,"role":64,"phone":65,"phoneExt":41,"email":69},"Yanjuan Zhu, MD","zyjsophy@gzucm.edu.cn",[71,89,102,114,128,143],{"facility":72,"status":41,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Beijing chest Hospital","Beijing","Beijing Municipality","100000","China","CN",{"type":79,"coordinates":80},"Point",[81,82],116.39723,39.9075,{"lat":82,"lon":81},[85],{"name":86,"role":64,"phone":87,"phoneExt":41,"email":88},"Ying Hu","86-010-89509324","huying@bjxkyy.en",{"facility":90,"status":41,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Guang'anmen Hospital of china Academy of chinese Medical Sciences",{"type":79,"coordinates":92},[81,82],{"lat":82,"lon":81},[95,99],{"name":96,"role":64,"phone":97,"phoneExt":41,"email":98},"Ying Zhang","86-010-83123311","zylzy501@163.com",{"name":100,"role":64,"phone":97,"phoneExt":41,"email":101},"Kainan Zhou","zhoukn21@163.com",{"facility":103,"status":41,"city":104,"state":105,"zip":106,"country":76,"countryCode":77,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Guangdong Provincial Hospital of Traditional Chinese Medicine","Guangzhou","Guangdong","510000",{"type":79,"coordinates":108},[109,110],113.25,23.11667,{"lat":110,"lon":109},[113],{"name":63,"role":64,"phone":65,"phoneExt":41,"email":66},{"facility":115,"status":41,"city":116,"state":117,"zip":41,"country":76,"countryCode":77,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Affiliated Hospital of Xinxiang Medical University, Henan province","Weihui","Henan",{"type":79,"coordinates":119},[120,121],114.0592,35.40747,{"lat":121,"lon":120},[124],{"name":125,"role":64,"phone":126,"phoneExt":41,"email":127},"Xiaohong Kang","86-0373-4403114","kxhhgd@163.com",{"facility":129,"status":41,"city":130,"state":131,"zip":132,"country":76,"countryCode":77,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Yueyang Hospital of Integrated Traditional Chinese and Western Medicine","Shanghai","Shanghai Municipality","200437",{"type":79,"coordinates":134},[135,136],121.45806,31.22222,{"lat":136,"lon":135},[139],{"name":140,"role":64,"phone":141,"phoneExt":41,"email":142},"DI Zhou","86-021-65162628","judy_36zzzzz@126.com",{"facility":144,"status":41,"city":145,"state":146,"zip":147,"country":76,"countryCode":77,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Sichuan Cancer Hospital and Research Institute","Chengdu","Sichuan","610040",{"type":79,"coordinates":149},[150,151],104.06667,30.66667,{"lat":151,"lon":150},[154,158],{"name":155,"role":64,"phone":156,"phoneExt":41,"email":157},"Wei Dai","86-020-85420366","davii-i@126.com",{"name":159,"role":64,"phone":156,"phoneExt":41,"email":160},"Jia Liao","709524124@qq.com",{"type":162,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[164,166,168,169,170],{"name":165,"class":6},"Beijing Chest Hospital",{"name":167,"class":6},"Guang'anmen Hospital of China Academy of Chinese Medical Sciences",{"name":144,"class":6},{"name":129,"class":6},{"name":115,"class":171},"UNKNOWN","100618959",false,"NCT07338396","A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients","A Clinical Study on the Patterns of Traditional Chinese Medicine Syndromes and Efficacy Differences in Lung Cancer Patients Treated With EGFR-TKI","Inclusion Criteria:\n\n* Pathologically or histologically confirmed non-small cell lung cancer (NSCLC)\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Presence of epidermal growth factor receptor (EGFR) mutation confirmed by genetic testing\n\nPostoperative Cohort (must meet all of the above and the following):\n\n* Have undergone curative surgery for lung cancer with R0 resection\n* Are planned to receive or are currently receiving postoperative EGFR-TKI adjuvant therapy within 2 weeks\n\nAdvanced Cohort (must meet all of the above and the following):\n\n* Meet stage IIIB-IV criteria according to the 9th edition of the American Joint Committee on Cancer (AJCC), or have stage IIIB or below disease but have refused or are unable to tolerate surgical treatment\n* Have at least one measurable lesion\n* Are planned to receive or are currently receiving first-line EGFR-TKI therapy within 2 weeks\n\nExclusion Criteria:\n\n* Unable to comply with baseline assessments\n* Pregnant or breastfeeding women\n* Presence of other uncontrolled malignancies\n* Presence of severe brain diseases or psychiatric disorders that affect the patient's ability to communicate or provide informed consent\n* Individuals without legal capacity, or those with medical or ethical reasons preventing continued participation in the study\n* Refusal to sign the informed consent form","ALL","18 Years",{"count":181,"type":182},3000,"ESTIMATED","3 Years","OBSERVATIONAL","The goal of this observational study is to learn about the relationship between TCM body constitution patterns (called \"syndromes\") and the effectiveness of EGFR-TKI targeted drugs in patients with lung cancer. Approximately 3000 patients with EGFR-mutant non-small cell lung cancer who are about to start or are already taking EGFR-TKI drugs as part of their regular medical care will be invited to join. Participants will be followed for up to 5 years. During routine clinic visits, researchers will collect their TCM information (such as tongue images and pulse readings) and store small samples of their blood, stool, and tongue coating for future research.",[187],"Non Small Cell Lung Cancer NSCLC",[187,189,190,58],"Traditional Chinese Medicine Syndromes","Efficacy","NOT_YET_RECRUITING","2026-01-05",{"date":194,"type":195},"2026-01-13","ACTUAL",{"date":197,"type":182},"2026-01",{"date":199,"type":182},"2031-07",{"name":5,"class":6},6]