Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung

Study Overview
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Brief Summary
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2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.

Detailed Description
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The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. Study duration: Expected patient enrollment to be completed within 12 months after study initiation. Patients will be followed for a minimum of 12 months from the date of enrollment. The study duration is approximately 2 years. Participant duration: The day of blood collection. Participants will follow their regular standard of care schedule as recommended by existing guidelines; no extra visits are planned. Follow up data will be obtained from the electronic medical record within at least 12 months of follow-up period.

Official Title
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Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung Early Detection of Lung Cancer Based on Small RNA Signatures - Boston II

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: miLungDx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male and female patients, aged 50 to 80 years Received a lung RADS category 3 or 4 finding on a LDCT screening exam (first or subsequent) and are referred to undergo further diagnostic procedures for the detection of lung cancer Has undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period Subject may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule Able and willing to provide informed consent Exclusion Criteria: Prior history of diagnosed lung cancer History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis) Immunosuppressive medication Deemed not able to participate in the study by the investigator

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: miLungDx|At study enrollment a blood sample will be drawn prior to any invasive diagnostic study or treatment. On this blood sample a novel lung cancer test relying on small RNA signatures will be performed and evaluated.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective | The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. The primary endpoint is to detect the presence or absence of lung cancer, as determined by all follow-up imaging, and pathological data obtained throughout the duration of the study. | 1 year |