[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07216144":3,"trial-entities:NCT07216144":92,"trial-summary:NCT07216144":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":39,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":71,"locations":74,"central_contacts":83,"overall_officials":84,"references":90,"see_also_links":91},"NCT07216144","25-04028716","Centralized Lung Cancer Screening Engagement in At-Risk Populations","Centralized Lung Cancer Screening Engagement in At-Risk Populations (CLEAR)","ENROLLING_BY_INVITATION","2027-08","2025-12","2025-12-10","2025-10-15","Weill Medical College of Cornell University","OTHER",false,"This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.","This will be a two-arm, parallel, pragmatic randomized controlled trial (RCT) to evaluate the effectiveness of a centralized patient outreach strategy in increasing lung cancer screening (LCS) completion among populations served by Federally Qualified Health Centers (FQHCs). This study will randomize individuals potentially eligible for LCS (50-80 years, current or past smokers) to receive centralized patient outreach in addition to usual care (outreach arm) and usual care alone (usual care arm). Individuals assigned to the outreach arm will receive centralized patient outreach from the Lung screening team through a letter followed by up to three attempts of telephone contact. Individuals assigned to the usual care arm will not receive any contact during the study period and the referral for LCS will be made at the treating physician's discretion.",[19],"Lung Cancer Screening",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},2000,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Centralized patient outreach for lung cancer screening","Centralized patient outreach for lung cancer screening will be conducted by the lung screening team and will consist of a letter followed by telephone contact. One week following the mail invitation, a senior patient coordinator (SPC) will make telephone contact with individuals to pre-screen eligibility determination based on pack-year smoking history. Up to three telephone contact attempts will be made within two weeks.",[34],"Outreach arm",[36],{"measure":37,"timeFrame":38},"Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization.","Within 15 months of randomization",[40,43,46,50],{"measure":41,"description":42,"timeFrame":38},"LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS)","Proportion of individuals with Lung-RADS 1, 2, 3, and 4",{"measure":44,"description":45,"timeFrame":38},"LDCT incident findings","Proportion of individuals with incident findings on LDCT (including moderate to severe coronary artery calcification, lung-mediastinal findings, moderate to severe emphysema, and abdominal findings)",{"measure":47,"description":48,"timeFrame":49},"Follow-up care","Proportion of individuals receiving a biopsy or lung cancer treatment","Within 6 months after screening",{"measure":51,"timeFrame":38},"Average costs of implementing centralized outreach per individual","ALL","50 Years","80 Years",{"inclusion":56,"exclusion":63,"raw_text":70},[57,58,59,60,61,62],"Adults aged 50 to 80 years","Current or past smokers","Individuals without a recorded LDCT scan within the past year","Individuals without a prior lung cancer diagnosis","Active patients of Ryan Health","Individuals with a mailing address in the New York City area and a phone number on file",[64,65,66,67,68,69],"Individuals aged less than 50 or above 80 years","Individuals without smoking history","Individuals with a recorded LDCT scan within the past year","Individuals with a prior lung cancer diagnosis","Individuals without a mailing address in the New York City area or a phone number on file","Individuals served by one of Ryan Health clinics where the centralized patient outreach was developed","Inclusion Criteria:\n\n* Adults aged 50 to 80 years\n* Current or past smokers\n* Individuals without a recorded LDCT scan within the past year\n* Individuals without a prior lung cancer diagnosis\n* Active patients of Ryan Health\n* Individuals with a mailing address in the New York City area and a phone number on file\n\nExclusion Criteria:\n\n* Individuals aged less than 50 or above 80 years\n* Individuals without smoking history\n* Individuals with a recorded LDCT scan within the past year\n* Individuals with a prior lung cancer diagnosis\n* Individuals without a mailing address in the New York City area or a phone number on file\n* Individuals served by one of Ryan Health clinics where the centralized patient outreach was developed",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"city":77,"state":77,"zip":78,"country":79,"geoPoint":80},"Weill Cornell Medicine","New York","10065","United States",{"lat":81,"lon":82},40.71427,-74.00597,[],[85,88],{"name":86,"affiliation":13,"role":87},"Jialin Mao, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":89,"affiliation":13,"role":87},"Bradley B Pua, MD",[],[],{"nct_id":4,"conditions":93,"biomarkers":94},[19],[],{"nct_id":4,"found":15,"summary":96,"prompt_version":96},null]