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Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to <30 mm in Diameter, Determined by LDCT.

RecruitingNAAges 50 Years - 80 YearsAllbioAffinity Technologies Inc.
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In plain words

What the trial is, and whether it could suit you

Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, \>6 to \<30 mm in Diameter, Determined by LDCT.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Is able to give signed informed consent and comply with study requirements. 2. Is high risk for getting lung cancer: 1. โ‰ฅ50 - 80 years of age. 2. current smoker with smoking history of at least 20 pack-years or current non-smoker with smoking history of at least 20 pack-years who quit smoking within the past 15 years. 3. Has a \>6 to \<30 mm diameter lung nodule (found by lung cancer screening or found incidentally by CT scan) as determined by CT and is willing to provide a sputum sample for FlowPath Lung test within 12 weeks (3 months) of the prestudy baseline CT scan. 3a) Nodule is either new, increasing, or stable for โ‰ค 6 months. 3b) In cases where a person has multiple nodules as determined by CT scan, the subject's most suspicious nodule is \>6 to \<30 mm in diameter. 4\) Is willing to provide contact information to the study PI or the treating physician(s) who can release required medical information related to SOC follow-up. Exclusion Criteria: 1. Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease). 2. The dominant nodule is ground glass or part solid as determined by CT scan. 3. Has 5 or more nodules sized \>4 mm. 4. The nodule sized \>6 to \<30 mm in diameter is a perifissural nodule. 5. Is immunosuppressed. 6. Has rheumatoid arthritis. 7. Had lung cancer diagnosis in the past 5 years or any other cancer (other than non-melanoma skin cancer) in the past 2 years. A subject on long-term medications used for prevention of cancer, such as Tamoxifen for breast cancer, is not excluded. 8. Has angina with minimal exertion. 9. Is currently pregnant or planning on becoming pregnant during this study.
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What it tests

  • Standard medical treatment
  • Standard medical treatment
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Where

11 sites
VA Palo Alto Health Care System
Palo Alto, United States
VA Western Colorado Health Care System
Grand Junction, United States
Bay Pines VA Healthcare System
Bay Pines, United States
Miami VA Healthcare System
Miami, United States
James A. Haley Veterans' Hospital
Tampa, United States
Captain James A. Lovell Federal Health Care Center
North Chicago, United States
Dayton VA Medical Center
Dayton, United States
Clinical Research Associates of Central Pennsylvania
DuBois, United States

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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