Lung Cancer, Lung Nodule
Conditions
Brief summary
The purpose of this study is to test whether combining a unique analytical approach with changes in platelet RNA expression accurately diagnoses lung cancer. Using retrospective platelet transcriptomic data from 522 patients with non-small cell lung cancer (NSCLC, the most common type of lung cancer), an approach that appears to accurately classify lung cancer has been developed. The study will build upon these retrospective analyses to prospectively recruit patients with newly diagnosed lung cancer, obtain platelet RNA samples from whole blood, and perform validation analyses. This research will also test whether this approach accurately distinguishes benign from malignant lung nodules.
Interventions
DIAGNOSTIC_TESTPlatelet RNA-based assay
Up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes. The minimum whole blood collected will be 4mL.
Sponsors
University of Utah
United States Department of Defense
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Study Population 1: Treatment-Naïve Patients with a Lung Nodule or Lung Cancer Inclusion Criteria: * Aged 21 years or older * Meeting at least one of the following two criteria: * Diagnosed with any stage or type of lung cancer * Having at least one lung nodule identified on imaging (e.g., low dose computed tomography \[LDCT\] or other diagnostic chest imaging) that was completed within 180 days prior to enrollment, and where there is planned or recommended biopsy, surgical resection, radiation therapy, systemic therapy, or other invasive diagnostic or therapeutic procedure to further evaluate the nodule(s) in the next six months based on the clinical judgment of the patient's provider(s)
Exclusion criteria
* Other diagnosis of, or treatment for, any cancer within the last 6 months except for non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade prostate cancer (defined as Gleason score ≤ 6) treated locally * A history of lung cancer or metastatic cancer to the lungs from an extrathoracic primary site with definitive treatment (surgical, medical, or radiotherapy) within the past 2 years * Currently receiving any systemic therapy (chemotherapy, immunotherapy, and/or targeted therapy) or radiation therapy for lung cancer * Already undergone surgical resection of the lung cancer in part or in whole * Have undergone invasive diagnostic or therapeutic procedures (e.g., biopsy, surgery) related to the lung nodule within the past 3 months * Unable to provide blood sample Study Population 2: Control Subjects Inclusion Criteria: * Aged 21 years or older
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | up to one day after study enrollment | Sensitivity of the assay in detecting lung cancer |
| Specificity | up to one day after study enrollment | Specificity of the assay in detecting lung cancer. |
| Positive predictive value (PPV) | up to one day after study enrollment | Positive predictive value (PPV) in distinguishing benign vs. malignant lung nodules. |
| Negative Predictive Value (NPV) | up to one day after study enrollment | Negative predictive value (NPV) in distinguishing benign vs. malignant lung nodules. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance Across Lung Cancer Stage | up to one day after study enrollment | Performance of the assay across lung cancer stage (stage I-IV). |
| Performance Across Lung Cancer Histologic Subtypes | up to one day after study enrollment | Performance of assay across lung cancer histologic subtypes (e.g., adenocarcinoma, squamous, small cell). |
| Validation Completion | up to one day after study enrollment | Technical and analytical validation completion. |
Countries
United States
Contacts
CONTACTMatthew Rondina, MD, MS
PRINCIPAL_INVESTIGATORShiven Patel, MD/MBA
University of Utah
Outcome results
None listed