[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591379":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":20,"overallStatus":69,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-Arm - ctDNA-Guided Treatment","EXPERIMENTAL","This single-group interventional arm evaluates the feasibility and impact of ctDNA testing in guiding adjuvant treatment decisions.",[13],"Diagnostic Test: Haystack™ ctDNA Assay",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Haystack™ ctDNA Assay","A personalized, tumor-informed circulating tumor DNA (ctDNA) test that analyzes blood samples to detect minimal residual disease (MRD) and guide postoperative treatment decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) following surgical resection. The test results will help determine whether patients should receive postoperative radiation therapy (PORT) and\u002For systemic therapy adjustments.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Salma Jabbour, MD","CONTACT","732-235-2465","jabbousk@cinj.rugers.edu",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Rutgers Cancer Institute","New Brunswick","New Jersey","08901","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-74.45182,40.48622,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":43},"jabboursk@cinj.rutgers.edu",{"type":45,"investigatorFullName":23,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Professor of Radiation Oncology","100591379","early-phase-1-trial-of-ctdna-of-guidance-to-determine-postoperative-radiation-therapy-100591379",false,"NCT06979661","Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy","Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial","PORT","Inclusion Criteria:\n\n1. Have provided signed informed consent for the trial\n2. Aged ≥18 years at the time of informed consent\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n4. Diagnosed with histologically confirmed Stage II-III NSCLC and undergone surgical resection of lung tumor\n5. No active second cancers\u002Fmalignancy\n6. Patients that received preoperative therapy (including chemotherapy and immunotherapy or others) are eligible\n7. Willing and able to comply with all aspects of the protocol\n8. Standard of care therapy and methods as per institution and investigator discretion -\n\nExclusion Criteria:\n\nExclusion Criteria\n\n1. Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent\n2. With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician.\n3. Have known active CNS metastases and\u002For carcinomatous meningitis.\n4. Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.\n5. Have a history of interstitial lung disease.\n6. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. -","ALL","18 Years","90 Years",{"count":59,"type":60},25,"ESTIMATED","INTERVENTIONAL",[63],"EARLY_PHASE1","Primary Objective:\n\nEvaluate the role of ctDNA positivity in decision making for postoperative therapy for non-small cell lung cancer. The plan for postoperative therapy will be declared after pathology report review and before the ctDNA result. We will assess if ctDNA result changed the planned therapy.\n\nSecondary Objectives:\n\nEvaluate personalized postoperative Chemo\u002FICPI\u002FTargeted Therapies\u002FRadiation Therapy in clearing ctDNA Evaluate the disease-free survival (DFS) and overall survival (OS) of stage II\u002FIII lung cancer patients with postoperative ctDNA positive status\n\nExploratory Objective:\n\nEvaluate radiomics features based on serial CT thoracic CT scans to determine if radiomic features can be associated with ctDNA positivity\u002Fnegativity.",[66,67,68],"Lung Cancer","Non Small Cell Lung Cancer","Lung Cancer Recurrent","NOT_YET_RECRUITING","2025-05-13",{"date":72,"type":73},"2025-05-20","ACTUAL",{"date":75,"type":60},"2025-06-01",{"date":77,"type":60},"2029-06-01",{"name":5,"class":6},1]