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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an AI blood test that looks at RNA, messages inside cells, in platelets, which help blood clot. It checks whether the test can find lung cancer and tell cancerous lung spots from noncancerous spots. Adults age 21 or older with untreated lung cancer or a lung spot, and adults in a comparison group, may join.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: You must be age 21 or older.
  • Lung cancer or lung spot group: You must have lung cancer of any type or stage, OR meet the lung spot rules below.
  • Lung spot rules: A chest scan within 180 days before joining must show at least one lung nodule (spot). Your care team must plan or recommend a biopsy (tissue sample), surgery, radiation, medicine, or another procedure to check or treat it within the next 6 months.

Who can't join

  • Both groups: You cannot give a blood sample.
  • Cancer rules: For the lung cancer or lung spot group, another cancer diagnosis or treatment in the past 6 months rules you out. For the comparison group, any current cancer, or cancer diagnosis or treatment in the past 6 months, rules you out. Exceptions are non-melanoma skin cancer, cancer limited to the surface of the cervix, or low-grade prostate cancer (Gleason score 6 or less) treated only in that area.
  • Lung cancer or lung spot group: You had treatment in the past 2 years for earlier lung cancer or cancer that spread to the lungs from outside the chest.
  • Lung cancer or lung spot group: You are getting cancer medicines or radiation for lung cancer, have had some or all of it removed by surgery, or had a biopsy, surgery, or other procedure for the lung spot in the past 3 months.
  • Comparison group: You have ever had lung cancer, or you are pregnant or were pregnant in the past 12 weeks.
  • Comparison group: In the past 8 weeks, you had a hospital stay, surgery other than minor surgery such as mole removal, or a transfusion of blood or blood products.
  • Comparison group: You have kidney failure (kidney filtering score below 60 or need for dialysis), liver failure under the study's rules, or heart failure at stage C or D.
  • Comparison group: You had a blood clot in a vein, heart attack, or stroke in the past 8 weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

UT