NCT07460440 SPARC - Screening for Lung Cancer With Platelets Via an AI-enabled RNA-based Classifier
| NCT ID | NCT07460440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2026-09-08 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2026-09-08 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Study Population 1: Treatment-Naïve Patients with a Lung Nodule or Lung Cancer Inclusion Criteria: * 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) 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 Inclusion Criteria: * Aged 21 years or older Exclusion Criteria: * 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 * Renal failure (defined as eGFR \< 60 mL/min/1.73m² or on dialysis) * Liver failure (defined as having hepatic encephalopathy of any degree, OR moderately severe coagulopathy defined as INR ≥ 1.5, OR known cirrhosis, OR ALT of ≥ 10X ULN, OR total bilirubin of ≥ 3.0 mg/dL, OR diagnosis of liver failure) * Decompensated or end-stage heart failure (defined as ACC/AHA Stage C or Stage D heart failure) * Venous thrombosis, myocardial infarction, or stroke within the last 8 weeks * Currently pregnant or have been pregnant within the last 12 weeks * Any blood product transfusion within the last 8 weeks * Personal history of lung cancer at any time * Unable to provide blood sample
Contact & Investigator
Shiven Patel, MD/MBA
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT07460440 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07460440 currently recruiting?
Yes, NCT07460440 is actively recruiting participants. Contact the research team at matthew.rondina@hsc.utah.edu for enrollment information.
Where is the NCT07460440 trial being conducted?
This trial is being conducted at Salt Lake City, United States, Salt Lake City, United States.
Who is sponsoring the NCT07460440 clinical trial?
NCT07460440 is sponsored by University of Utah. The principal investigator is Shiven Patel, MD/MBA at University of Utah. The trial plans to enroll 240 participants.
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