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SPARC - Screening for Lung Cancer With Platelets Via an AI-enabled RNA-based Classifier | Clinical Trials | Clareo Health

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

NCT07460440•University of Utah

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

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

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
•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
+8 more criteria

Locations (1)

University of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2028

Last Updated

March 10, 2026

Enrollment

240

ESTIMATED participants

Conditions

Lung CancerLung Nodule

Interventions

Platelet RNA-based assay

DIAGNOSTIC_TEST

Contacts

Matthew Rondina, MD, MS

CONTACT

801-587-8308 matthew.rondina@hsc.utah.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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