[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05665504":3,"trial-entities:NCT05665504":110,"trial-summary:NCT05665504":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":16,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":46,"sex":54,"minimum_age":55,"maximum_age":16,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":79,"locations":82,"central_contacts":101,"overall_officials":103,"references":105,"see_also_links":106},"NCT05665504","MCC-21767","Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer","RECRUITING","2028-02","2026-03","2026-04-01","2023-01-11","H. Lee Moffitt Cancer Center and Research Institute","OTHER",true,"This study is an observational study of blood and tissue biomarkers. Investigators plan to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to examine another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer. Finally, investigators plan to determine if one of the blood-based biomarkers can be used to detect any late cancer recurrence.",null,[18,19],"Lung; Node","Adenocarcinoma of Lung",[21,22],"Biomarkers","Lung Cancer Biomarkers","OBSERVATIONAL",[],{"count":26,"type":27},250,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIAGNOSTIC_TEST","DetermaRX","A lung tissue biomarker to risk stratify patients immediately after curative lung cancer resections into groups with low risk versus intermediate-high risk for recurrence of cancer. Intermediate-high risk patients will be advised to undergo adjuvant chemotherapy with the expectation of decreasing their chance of recurrence. The effectiveness and toxicity of the adjuvant chemotherapy itself is considered not part of the study-just the decision to recommend adjuvant chemotherapy is the study intervention. Investigators will then evaluate the long-term survival results of low-risk patients (no adjuvant treatment) and intermediate-high risk patients receiving adjuvant treatment versus intermediate-high risk patients who decline adjuvant therapy.",[34,35,36],"High-Risk for Recurrence That Accept Adjuvant Chemotherapy","High-Risk for Recurrence That Decline Adjuvant Chemotherapy","Low-Risk for Recurrence",[38,42],{"measure":39,"description":40,"timeFrame":41},"Disease Free Survival","Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death","Up to 5 years",{"measure":43,"description":44,"timeFrame":45},"Overall Survival","Overall survival (OS) is defined as the time (days) from the date of surgical resection and adjuvant chemotherapy to the date of death, due to any reason.","Up to 5 Years",[47,51],{"measure":48,"description":49,"timeFrame":50},"Tumor Malignancy","Fisher exact test will used to test association of both LCDT1™, NodifyXL2®, and CIZ1b™ blood tests with malignancy.","At 6 Months",{"measure":52,"description":53,"timeFrame":50},"Cancer Recurrence","Fisher exact test will used to test association of LCDT-1™ blood test with cancer recurrence.","ALL","18 Years",false,{"inclusion":58,"exclusion":67,"raw_text":78},[59,60,61,62,63,64,65,66],"Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer \\[clinical stage IA-IB (cT1a-T2aN0), \\\u003C4cm diameter\\].","If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.","If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.","\\>18 years old, male or female.","ECOG performance status 0-1.","Agree to participate in the follow-up protocol.","Any suspected primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma).","Ability to understand and the willingness to sign a written, informed consent document.",[68,69,70,71,72,73,74,75,76,77],"Participants who are actively receiving any cancer treatment.","Participants with uncontrolled intercurrent illness.","Prior lung cancer within 5 years.","Current active other major cancer except non-melanoma skin cancer.","Patients with pure ground glass opacities (nodules) or hilar masses.","Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma).","Metastatic nodule (suspected) in the lung from an extrapulmonary cancer.","Patient unable to provide informed consent.","Prisoner or incarcerated individual.","For surgical patients, a R1 or R2 resection.","Inclusion Criteria:\n\n* Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer \\[clinical stage IA-IB (cT1a-T2aN0), \\\u003C4cm diameter\\].\n* If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.\n* If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.\n* \\>18 years old, male or female.\n* ECOG performance status 0-1.\n* Agree to participate in the follow-up protocol.\n* Any suspected primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma).\n* Ability to understand and the willingness to sign a written, informed consent document.\n\nExclusion Criteria:\n\n* Participants who are actively receiving any cancer treatment.\n* Participants with uncontrolled intercurrent illness.\n* Prior lung cancer within 5 years.\n* Current active other major cancer except non-melanoma skin cancer.\n* Patients with pure ground glass opacities (nodules) or hilar masses.\n* Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma).\n* Metastatic nodule (suspected) in the lung from an extrapulmonary cancer.\n* Patient unable to provide informed consent.\n* Prisoner or incarcerated individual.\n* For surgical patients, a R1 or R2 resection.",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":84,"status":7,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":98},"Moffitt Cancer Center","Tampa","Florida","33612","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"Brianna Aponte","CONTACT","813-745-0787","Brianna.Aponte@moffitt.org",{"name":96,"role":97},"Lary A Robinson, MD","PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},27.94752,-82.45843,[102],{"name":91,"role":92,"phone":93,"email":94},[104],{"name":96,"affiliation":84,"role":97},[],[107],{"label":108,"url":109},"Moffitt Cancer Center Clinical Trial Search","https:\u002F\u002Fmoffitt.org\u002Fclinicaltrialssearch?DiseaseSite=&q=21767&SortCriteria=",{"nct_id":4,"conditions":111,"biomarkers":113},[112],"Lung Carcinoma",[],{"nct_id":4,"found":14,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an observational study, meaning researchers will collect information without giving any specific treatments. It aims to enroll 250 participants.","completed","Observational Study of Biomarkers for Lung Cancer Diagnosis and Recurrence","This observational study is looking at ways to better diagnose lung cancer and predict if it will come back. Researchers are studying biomarkers, which are substances in your body that can indicate disease. They want to see if biomarkers in your blood can tell if a lung nodule (a small growth) is cancer or not. They are also examining a biomarker called DetermaRX in tumor tissue after surgery to identify patients at high risk for cancer recurrence. Finally, they will investigate if a blood biomarker can detect cancer coming back later. This study is for people aged 18 and older with a suspected lung cancer nodule (8-40 mm) that is potentially removable by surgery. The study aims to understand how these biomarkers relate to how long patients live without the disease returning (Disease Free Survival) and overall survival, both measured for up to 5 years. The current recruitment status is unclear, and the study plans to enroll 250 participants.","Participants will be followed for up to 5 years to measure disease-free survival and overall survival.",159,"If you are recommended for surgery, you would undergo surgery at Moffitt Cancer Center. The study involves collecting blood and tissue samples.","Not stated in the trial record.",[31],"v2"]