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

ConditionsLung Cancer Lung Nodule

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age21+

SponsorUniversity of Utah

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Aged 21 years or older

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)

Disqualifiers

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

Trial population

The population from which the cohorts will be selected will be from the Huntsman Cancer Institute University of Utah (HCI/UU) and the George E. Wahlen Veterans Affairs Medical Center (VAMC) in Salt Lake City, Utah.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

240 Participants

are divided into 3 treatment groups

Group A: Cohort 1: Lung Cancer1 intervention

Group B: Cohort 2: Lung Nodule1 intervention

Group C: Cohort 3: Control Participants without Cancer or Nodule1 intervention

Trial outcomes