Recruiting

Platelet RNA Analysis

Sponsor:

University of Utah

Code:

NCT07460440

Conditions

Lung Cancer

Lung Nodule

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Platelet RNA-based assay

Study Details

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.

Conditions

Lung Cancer

Lung Nodule

Study ID

NCT07460440

Start date

Sep 1, 2026

Status verified date

May, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Platelet RNA-based assay

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.

Primary outcome measure

  • Sensitivity [ Time Frame: up to one day after study enrollment ]
  • Specificity [ Time Frame: up to one day after study enrollment ]
  • Positive predictive value (PPV) [ Time Frame: up to one day after study enrollment ]
  • Negative Predictive Value (NPV) [ Time Frame: up to one day after study enrollment ]

Central Contacts and Locations

Central contacts

Matthew Rondina, MD, MS

801-587-8308matthew.rondina@hsc.utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Shiven Patel, MD/MBA

801-585-0255u0820856@umail.utah.edu

Principal Investigator:

Shiven Patel, MD/MBA

Veterans Affairs SLC Health Care System (VAMC)

Recruiting

Salt Lake City, Utah, United States, 84148-0001

Contacts

Emily Beck, MD

208-830-6514Emily.Beck@hsc.utah.edu

Principal Investigator:

Emily Beck, MD

More Information

Sponsor

University of Utah

Last update posted

Sep 3, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-09-03.