SPARC - Screening for Lung Cancer With Platelets Via an AI-enabled RNA-based Classifier
Starting soon
Conditions studied: Lung Cancer, Lung Nodule
In brief
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.
Key facts
- Study ID
- NCT07460440
- Run by
- University of Utah
- People needed
- 240
- Starts
- 2026-06-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
- Exclusion Criteria:
- 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
- Hospitalization or surgery (other than minor surgery such as mole removal) within the last 8 weeks
- 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)
- 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
- Currently pregnant or have been pregnant within the last 12 weeks
- Any blood product transfusion within the last 8 weeks
- Personal history of lung cancer at any time
- Unable to provide blood sample
Where it is running
- University of Utah — Salt Lake City, Utah, United States
- Veterans Affairs SLC Health Care System (VAMC) — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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