SPARC - Screening for Lung Cancer With Platelets Via an AI-enabled RNA-based Classifier
Trial statusNot yet recruiting
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
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 design
Treatments tested in this trial
- Platelet RNA-based assay
Treatment groups
240 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Utah
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov