[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528996":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":52,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":18,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vaccinated group","EXPERIMENTAL","Any booster doses(without limitations in the subtypes or brands of the vaccines) recommended or approved by Chinese government will be administered once in the 6th months after latest confirmed COVID-19 infection and during the following 6 months, any conditions including repeated COVID19 infection, critical and\u002For severe conditions and all-cause death will be recorded.",[13],"Biological: Any Chinese government-recommended COVID-19 booster vaccine",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-vaccinated group","NO_INTERVENTION","Patients unwilling to get vaccination will be allocated into these group, but any events including recurrent COVID19 infection, critical and\u002For severe conditions and all-cause death will be recorded in the following six months.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BIOLOGICAL","Any Chinese government-recommended COVID-19 booster vaccine","Any Chinese government-recommended COVID-19 booster vaccine(such as Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine(Sf9 Cell) and so on) will be once administered in the sixth month after COVID19 infection.",[9],[26],{"name":27,"affiliation":5,"role":28},"Mengzhao Wang, MD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+8613911235467","mengzhaowang@sina.com",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Yan Xu, MD","+8618500296828","maraxu@163.com",[39],{"facility":5,"status":40,"city":41,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Beijing","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100528996","covid-19-vaccine-effectiveness-against-recurrent-infection-among-lung-cancer-patients-and-biomarker-research-100528996",false,"NCT06168032","COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research","Efficacy of COVID-19 Booster-Dose Vaccine for Re-infection Precaution and Dynamics of Specific Serum Antibodies in the Management of Lung Cancer Patients With Systemic Anti-cancer Treatment","Inclusion Criteria:\n\n1. Patients who agree to participate in the trial and sign the informed consents.\n2. Male or female, ≥18 years old.\n3. Diagnosed of lung carcinoma by histological and cytological examinations.\n4. Undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy and targeted therapy.\n5. Recorded history of COVID19 infection.\n6. Sufficiently functional organs.\n7. Eastern Cooperative Oncology Group performance score (PS) ranging from 0 to 2.\n\nExclusion Criteria:\n\n1. Life expectance less than 3 months.\n2. Less than 3 months since last confirmed COVID-19 infection.\n3. Patients unable to return the hospital for follow-up.\n4. Patients allergic to COVID-19 vaccine.\n5. Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.","ALL","18 Years",{"count":64,"type":65},1224,"ESTIMATED","INTERVENTIONAL",[68],"NA","A prospective, open-label and parallel non-randomized control trial and biomarker research study is intended to compare incidence of repeated COVID-19 infection, severe pneumonitis and mortality between lung cancer patients undergoing systemic antitumor therapies who get vaccinated with 1 booster dose(majorly against XBB) and those who refuse. Meanwhile, a biomarker research is designed to monitor serum level dynamics of specific antibodies against COVID-19,analyze its correlation with incidence of breakthrough infection and further explore optimal periods for vaccination.",[71,72,73,74,75,76],"COVID-19 Recurrent","Lung Cancer","Vaccination","Antibody","Chemotherapy","Immune Checkpoint Inhibitor","2023-12-11",{"date":79,"type":80},"2023-12-13","ACTUAL",{"date":82,"type":65},"2023-12-08",{"date":84,"type":65},"2026-12-08",{"name":5,"class":6},1]