[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620522":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":39,"responsibleParty":78,"collaborators":81,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":30,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":30,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":109,"overallStatus":42,"whyStopped":30,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"National University Hospital, Singapore","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"High-Risk Individuals Without Known Lung Cancer","EXPERIMENTAL","High-risk individuals without a prior diagnosis of lung cancer undergo blood-based liquid biopsy testing followed by low-dose CT (LDCT) thorax screening as per the study protocol. Participants with positive liquid biopsy results and negative LDCT findings will be offered a study-funded CT-PET scan for further evaluation.",[13,14,15],"Diagnostic Test: Liquid Biopsy (SPOT-MAS Assay)","Diagnostic Test: Exosome-Based Liquid Biopsy Assay","Diagnostic Test: Low-Dose CT Thorax (LDCT)",{"label":17,"type":10,"description":18,"interventionNames":19},"Early-Stage Lung Cancer Patients (Stage I-II)","Participants with histologically confirmed early-stage lung cancer (Stage I-II) undergo blood collection for liquid biopsy testing to evaluate assay performance in early disease.",[13,14],{"label":21,"type":10,"description":22,"interventionNames":23},"Advanced-Stage Lung Cancer Patients (Stage III-IV)","Participants with histologically confirmed advanced-stage lung cancer (Stage III-IV) undergo blood collection for liquid biopsy testing to evaluate assay performance in advanced disease.",[13,14],[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIAGNOSTIC_TEST","Liquid Biopsy (SPOT-MAS Assay)","Blood-based genome-wide DNA methylation assay performed on plasma samples to detect tumor-associated methylation patterns suggestive of lung cancer.",[21,17,9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Exosome-Based Liquid Biopsy Assay","Blood-based assay analyzing exosome-associated biomarkers to support early detection of lung cancer.",[21,17,9],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Low-Dose CT Thorax (LDCT)","Low-dose computed tomography of the thorax performed for lung cancer screening",[9],[40],{"facility":41,"status":42,"city":43,"state":30,"zip":44,"country":43,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"National University Hospital Singapore","RECRUITING","Singapore","119228","SG",{"type":47,"coordinates":48},"Point",[49,50],103.85007,1.28967,{"lat":50,"lon":49},[53,58,61,63,66,68,70,72,74,76],{"name":54,"role":55,"phone":56,"phoneExt":30,"email":57},"Soo-Chin Lee, MMed","CONTACT","+6569082222","soo_chin_lee@nuhs.edu.sg",{"name":59,"role":60,"phone":30,"phoneExt":30,"email":30},"Soo-Chin Lee","PRINCIPAL_INVESTIGATOR",{"name":62,"role":60,"phone":30,"phoneExt":30,"email":30},"Kang Hoe Lee",{"name":64,"role":65,"phone":30,"phoneExt":30,"email":30},"Mamta Ruparel","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":30,"phoneExt":30,"email":30},"Adrian Kee",{"name":69,"role":65,"phone":30,"phoneExt":30,"email":30},"See Kay Choong",{"name":71,"role":65,"phone":30,"phoneExt":30,"email":30},"Yiqing Huang",{"name":73,"role":65,"phone":30,"phoneExt":30,"email":30},"Jeffrey Shuen Kai Ng",{"name":75,"role":65,"phone":30,"phoneExt":30,"email":30},"Ross Soo",{"name":77,"role":65,"phone":30,"phoneExt":30,"email":30},"Kenneth Sooi",{"type":60,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Haematology-Oncology","Prof. Lee Soo Chin",[82],{"name":83,"class":84},"Gene Solutions","INDUSTRY","100620522","liquid-biopsy-based-pre-screening-to-streamline-ldct-lung-cancer-screening-in-high-risk-individuals-100620522",false,"NCT07358715","Liquid Biopsy-Based Pre-Screening to Streamline LDCT Lung Cancer Screening in High-Risk Individuals","A Multimodal Liquid Biopsy-Based Assay as a Pre-Screening Test Before Low Dose CT Thorax (LDCT) to Streamline Lung Cancer Screening in High-Risk Individuals","Inclusion Criteria\n\nHigh-Risk Individuals (n = 100)\n\n* No prior history of lung cancer\n* Meets one of the following high-risk definitions:\n\n  * Current or former smoker (quit within the past 15 years), aged 55-74 years, with a smoking history of ≥30 pack-years; OR\n  * Never-smoker aged 55-75 years with a first-degree family history of lung cancer\n* Able and willing to provide written informed consent\n\nEarly-Stage Lung Cancer Patients (n = 20)\n\n* Aged ≥21 years\n* Histologically or clinically confirmed stage I-II lung cancer\n* Treatment-naïve (no prior surgery, chemotherapy, radiotherapy, or immunotherapy for lung cancer)\n* Able and willing to provide written informed consent\n\nAdvanced-Stage Lung Cancer Patients (n = 20)\n\n* Aged ≥21 years\n* Histologically or clinically confirmed stage III-IV lung cancer\n* Treatment-naïve (no prior systemic or local therapy for lung cancer)\n* Able and willing to provide written informed consent\n\nExclusion Criteria\n\nApplicable to All Participants\n\n* Pregnant or breastfeeding women\n* Inability or unwillingness to comply with study procedures\n\nHigh-Risk Individuals Only\n\n* Known allergy or contraindication to CT contrast agents\n* Prior low-dose CT (LDCT), CT thorax, or PET-CT performed within 12 months prior to enrollment\n\nLung Cancer Cohorts Only\n\n• Receipt of any prior cancer-directed treatment for lung cancer",true,"ALL","21 Years","75 Years",{"count":97,"type":98},140,"ESTIMATED","INTERVENTIONAL",[101],"NA","This study evaluates the feasibility and cost-effectiveness of using a blood-based liquid biopsy assay as a pre-screening tool before low-dose CT (LDCT) for lung cancer screening. By identifying individuals unlikely to have lung cancer, this approach aims to reduce unnecessary LDCT scans, radiation exposure, and healthcare costs, while improving early detection, particularly among high-risk individuals including never-smokers with a family history of lung cancer.",[104,105,106,107,108],"Lung Cancer","Lung Neoplasms","Early Lung Cancer Detection","Cancer Screening","High-Risk Populations",[110,111,112,113,114,115,116,117,118,119,120],"Liquid biopsy","DNA methylation","Exosomes","Blood-based screening","Low-dose CT","LDCT","Lung cancer screening","Early cancer detection","High-risk individuals","Never-smokers","Multimodal assay","2026-01-13",{"date":123,"type":124},"2026-01-22","ACTUAL",{"date":126,"type":124},"2024-11-01",{"date":128,"type":98},"2028-12-31",{"name":5,"class":6},1]