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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07460440
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Platelet RNA-based assay — DIAGNOSTIC_TEST
    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. The minimum whole blood collected will be 4mL.

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Sensitivity [ Time Frame: up to one day after study enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84112
Shiven Patel, MD/MBA
[email protected]
801-585-0255
Shiven Patel, MD/MBA (PRINCIPAL_INVESTIGATOR)
Veterans Affairs SLC Health Care System (VAMC)Salt Lake CityUtah84148-0001
Emily Beck, MD
[email protected]
208-830-6514
Emily Beck, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Salt Lake City, UT

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Utah· Salt Lake City, UTVeterans Affairs SLC Health Care System (VAMC)· Salt Lake City, UT

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