[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628346":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":68,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":10,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":10,"overallStatus":92,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Utah","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Lung Cancer",null,"Cohort 1 will enroll 90 participants with Lung Cancer (30 patients with Stage I\u002FII and 60 participants with Stage III\u002FIV).\n\nFollowing informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.",[13],"Diagnostic Test: Platelet RNA-based assay",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Lung Nodule","Cohort 1 will enroll 120 participants with Lung Nodules (72 patients with Benign Nodules and 48 participants with Malignant Nodules).\n\nFollowing informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3: Control Participants without Cancer or Nodule","Cohort 3 will enroll 30 participants without Lunch Cancer or lunch Nodules.\n\nFollowing informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Platelet RNA-based assay","Up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes. The minimum whole blood collected will be 4mL.",[9,15,19],[29],{"name":30,"affiliation":5,"role":31},"Shiven Patel, MD\u002FMBA","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Matthew Rondina, MD, MS","CONTACT","801-587-8308","matthew.rondina@hsc.utah.edu",[39,56],{"facility":5,"status":10,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Salt Lake City","Utah","84112","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-111.89105,40.76078,{"lat":49,"lon":48},[52,55],{"name":30,"role":35,"phone":53,"phoneExt":10,"email":54},"801-585-0255","u0820856@umail.utah.edu",{"name":30,"role":31,"phone":10,"phoneExt":10,"email":10},{"facility":57,"status":10,"city":40,"state":41,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Veterans Affairs SLC Health Care System (VAMC)","84148-0001",{"type":46,"coordinates":60},[48,49],{"lat":49,"lon":48},[63,67],{"name":64,"role":35,"phone":65,"phoneExt":10,"email":66},"Emily Beck, MD","208-830-6514","Emily.Beck@hsc.utah.edu",{"name":64,"role":31,"phone":10,"phoneExt":10,"email":10},{"type":69,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[71],{"name":72,"class":73},"United States Department of Defense","FED","100628346","sparc---screening-for-lung-cancer-with-platelets-via-an-ai-enabled-rna-based-classifier-100628346",false,"NCT07460440","SPARC - Screening for Lung Cancer With Platelets Via an AI-enabled RNA-based Classifier","SPARC","Study Population 1: Treatment-Naïve Patients with a Lung Nodule or Lung Cancer\n\nInclusion Criteria:\n\n* Aged 21 years or older\n* Meeting at least one of the following two criteria:\n* Diagnosed with any stage or type of lung cancer\n* Having at least one lung nodule identified on imaging (e.g., low dose computed tomography \\[LDCT\\] or other diagnostic chest imaging) that was completed within 180 days prior to enrollment, and where there is planned or recommended biopsy, surgical resection, radiation therapy, systemic therapy, or other invasive diagnostic or therapeutic procedure to further evaluate the nodule(s) in the next six months based on the clinical judgment of the patient's provider(s)\n\nExclusion Criteria:\n\n* Other diagnosis of, or treatment for, any cancer within the last 6 months except for non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade prostate cancer (defined as Gleason score ≤ 6) treated locally\n* A history of lung cancer or metastatic cancer to the lungs from an extrathoracic primary site with definitive treatment (surgical, medical, or radiotherapy) within the past 2 years\n* Currently receiving any systemic therapy (chemotherapy, immunotherapy, and\u002For targeted therapy) or radiation therapy for lung cancer\n* Already undergone surgical resection of the lung cancer in part or in whole\n* Have undergone invasive diagnostic or therapeutic procedures (e.g., biopsy, surgery) related to the lung nodule within the past 3 months\n* Unable to provide blood sample\n\nStudy Population 2: Control Subjects\n\nInclusion Criteria:\n\n* Aged 21 years or older\n\nExclusion Criteria:\n\n* Any active malignancy or diagnosis of cancer within the last 6 months except for non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade prostate cancer (defined as Gleason score ≤ 6) treated locally\n* Treatment for any cancer within the last 6 months except for non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade prostate cancer (defined as Gleason score ≤ 6) treated locally\n* Hospitalization or surgery (other than minor surgery such as mole removal) within the last 8 weeks\n* Renal failure (defined as eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m² or on dialysis)\n* Liver failure (defined as having hepatic encephalopathy of any degree, OR moderately severe coagulopathy defined as INR ≥ 1.5, OR known cirrhosis, OR ALT of ≥ 10X ULN, OR total bilirubin of ≥ 3.0 mg\u002FdL, OR diagnosis of liver failure)\n* Decompensated or end-stage heart failure (defined as ACC\u002FAHA Stage C or Stage D heart failure)\n* Venous thrombosis, myocardial infarction, or stroke within the last 8 weeks\n* Currently pregnant or have been pregnant within the last 12 weeks\n* Any blood product transfusion within the last 8 weeks\n* Personal history of lung cancer at any time\n* Unable to provide blood sample",true,"ALL","21 Years",{"count":85,"type":86},240,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to test whether combining a unique analytical approach with changes in platelet RNA expression accurately diagnoses lung cancer. Using retrospective platelet transcriptomic data from 522 patients with non-small cell lung cancer (NSCLC, the most common type of lung cancer), an approach that appears to accurately classify lung cancer has been developed.\n\nThe study will build upon these retrospective analyses to prospectively recruit patients with newly diagnosed lung cancer, obtain platelet RNA samples from whole blood, and perform validation analyses. This research will also test whether this approach accurately distinguishes benign from malignant lung nodules.",[90,91],"Lung Cancer","Lung Nodule","NOT_YET_RECRUITING","2026-05-12",{"date":95,"type":96},"2026-05-15","ACTUAL",{"date":98,"type":86},"2026-06",{"date":100,"type":86},"2028-06",{"name":5,"class":6},2]