SPARC - Screening for Lung Cancer With Platelets Via an AI-enabled RNA-based Classifier

Prior treatment

• Currently receiving any systemic therapy (chemotherapy, immunotherapy, and/or targeted therapy) or radiation therapy for lung cancer
• Have undergone invasive diagnostic or therapeutic procedures (e.g., biopsy, surgery) related to the lung nodule within the past 3 months
• Hospitalization or surgery (other than minor surgery such as mole removal) within the last 8 weeks

Other illness

• 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
• Already undergone surgical resection of the lung cancer in part or in whole
• Any active malignancy or diagnosis of 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
• 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
• Decompensated or end-stage heart failure (defined as ACC/AHA Stage C or Stage D heart failure)
• Venous thrombosis, myocardial infarction, or stroke within the last 8 weeks
• Personal history of lung cancer at any time

Lab values

• Renal failure (defined as eGFR \< 60 mL/min/1.73m² or on dialysis)
• Liver failure (defined as having hepatic encephalopathy of any degree, OR moderately severe coagulopathy defined as INR ≥ 1.5, OR known cirrhosis, OR ALT of ≥ 10X ULN, OR total bilirubin of ≥ 3.0 mg/dL, OR diagnosis of liver failure)

Other

• Unable to provide blood sample
  • Study Population 2: Control Subjects
• Currently pregnant or have been pregnant within the last 12 weeks
• Any blood product transfusion within the last 8 weeks
• Unable to provide blood sample

• 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)
• Aged 21 years or older

Criteria the registry did not label

• Study Population 1: Treatment-Naïve Patients with a Lung Nodule or Lung Cancer