Not Yet RecruitingNot applicableNCT07460440

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

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.

Checked against the public recordLast updated May 15, 2026 · Source: ClinicalTrials.gov

StatusNot Yet Recruiting
PhaseNot applicable
U.S. locations2
SponsorUniversity of Utah
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
University of Utah
Interventions being studied
Diagnostic Test: Platelet RNA-based assay
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of UtahSalt Lake City, Utah
  • Veterans Affairs SLC Health Care System (VAMC)Salt Lake City, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 15, 2026. Always confirm current availability with the study team.

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