Lung cancer and lung nodules: platelet RNA classifier test
Official title: SPARC - Screening for Lung Cancer With Platelets Via an AI-enabled RNA-based Classifier
Run by University of Utah · NCT07460440 · Data updated 2026-11-12
This study tests whether a platelet RNA-based test can help distinguish lung cancer from benign nodules in adults who have a new lung finding or cancer diagnosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Salt Lake City, Utah and 1 other locations) |
| Status | Recruiting |
| Started | September 8, 2026 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07460440 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 21 years or older with a lung nodule identified on imaging or with a new lung cancer diagnosis, who have not yet started cancer-directed therapy.
✕Probably not a fit
Patients whose nodules are clearly benign or whose nodules do not reflect cancer biology may not benefit from this diagnostic approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will prospectively collect platelet RNA from adults with newly diagnosed lung cancer or lung nodules and apply an AI-enabled RNA classifier previously developed from retrospective data. The goal is to validate whether this blood-based test can accurately separate malignant from benign nodules and help characterize lung cancer. The study builds on analyses from 522 NSCLC patients and uses whole-blood platelet RNA to support diagnostic decisions alongside standard care. Enrollment targets treatment-naïve individuals and allows inclusion of those undergoing planned diagnostic or therapeutic procedures within six months. The design is observational and involves validation analyses rather than an interventional treatment.
Why it matters
Potential benefit: If successful, the test could provide a noninvasive option to help clinicians distinguish malignant from benign lung nodules and aid early cancer detection.
How similar studies have gone: Previous retrospective analyses showed promise in classifying lung cancer using platelet RNA, and this study seeks prospective validation.
Who can join: the full rules
Show full inclusion / exclusion 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 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's running
-
University of Utah
Salt Lake City, Utah, United States Recruiting -
Veterans Affairs SLC Health Care System (VAMC)
Salt Lake City, Utah, United States Recruiting
Study contacts
- Principal investigator: Shiven Patel, MD/MBA — University of Utah
- Study coordinator: Matthew Rondina, MD, MS
- Email: matthew.rondina@hsc.utah.edu
- Phone: 801-587-8308
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.