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.

Официальное название

Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Standard medical treatment
  Standard of care follow up per institution
• Другое Standard medical treatment
  SOC per institution

Первичные конечные точки

• Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum [Срок оценки: From Baseline Sputum Sample provided by subject through 24 months follow up period.]

Критерии участия

Критерии включения

• Is able to give signed informed consent and comply with study requirements.
• Is high risk for getting lung cancer:

• ≥50 - 80 years of age.
• 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.
• 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 6 weeks of the prestudy baseline CT scan.

3a) Nodule is either new, increasing, or stable for ≤ 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.

Критерии исключения

• Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease).
• The dominant nodule is ground glass or part solid as determined by CT scan.
• Has 5 or more nodules sized >4 mm.
• The nodule sized >6 to <30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule.
• Is immunosuppressed.
• Has rheumatoid arthritis.
• 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.
• Has angina with minimal exertion.
• Is currently pregnant or planning on becoming pregnant during this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 11 центров

• VA Palo Alto Health Care System — Palo Alto
• VA Western Colorado Health Care System — Grand Junction
• Bay Pines VA Healthcare System — Bay Pines
• Miami VA Healthcare System — Miami
• James A. Haley Veterans' Hospital — Tampa
• Captain James A. Lovell Federal Health Care Center — North Chicago
• Dayton VA Medical Center — Dayton
• Clinical Research Associates of Central Pennsylvania — DuBois
• … и ещё 3 центра

Идентификаторы

NCT: NCT07168993 · BA-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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