Lung Nodules Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: t
View:

• 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

Locations
United States
Utah
University of Utah
RECRUITING
Salt Lake City
Veterans Affairs SLC Health Care System (VAMC)
RECRUITING
Salt Lake City
Contact Information
Primary
Matthew Rondina, MD, MS
matthew.rondina@hsc.utah.edu
801-587-8308
Time Frame
Start Date: 2026-09-01
Estimated Completion Date: 2028-06
Participants
Target number of participants: 240
Treatments
Cohort 1: Lung Cancer
Cohort 1 will enroll 90 participants with Lung Cancer (30 patients with Stage I/II and 60 participants with Stage III/IV).~Following informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.
Cohort 2: Lung Nodule
Cohort 1 will enroll 120 participants with Lung Nodules (72 patients with Benign Nodules and 48 participants with Malignant Nodules).~Following informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.
Cohort 3: Control Participants without Cancer or Nodule
Cohort 3 will enroll 30 participants without Lunch Cancer or lunch Nodules.~Following informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.
Sponsors
Leads: University of Utah
Collaborators: United States Department of Defense

This content was sourced from clinicaltrials.gov