Blood test for diagnosing lung cancer in patients with suspicious CT results

Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung "Early Detection of Lung Cancer Based on Small RNA Signatures - Boston II"

This study is testing a new blood test to see if it can help find lung cancer earlier in people aged 50-80 who have had concerning results from a lung CT scan.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Hummingbird Diagnostics (Industry-sponsored)
• Locations: 8 sites (Atlanta, Georgia and 7 other locations)
• Trial ID: NCT05987189 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the diagnostic performance of a novel small RNA blood test in individuals aged 50-80 who have received a lung-RADS category 3 or 4 result from low-dose CT screening for lung cancer. The study will enroll approximately 2,000 participants who are scheduled for follow-up imaging or procedures. Participants will provide blood samples and will be followed for at least 12 months to assess the effectiveness of the test in detecting early-stage lung cancer. No additional visits are required beyond standard care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 to 80 who have received a lung-RADS category 3 or 4 finding on a recent low-dose CT scan.

Not a fit: Patients with a prior history of lung cancer or other specified cancers within the last 10 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this blood test could provide a less invasive method for early detection of lung cancer, potentially improving patient outcomes.

How similar studies have performed: While the approach of using blood tests for cancer diagnosis is gaining traction, this specific study's methodology is novel and has not been extensively tested in similar contexts.

Eligibility criteria

Inclusion Criteria:

* Adult male and female patients, aged 50 to 80 years
* Received a lung RADS category 3 or 4 finding on a LDCT screening exam (first or subsequent) and are referred to undergo further diagnostic procedures for the detection of lung cancer
* Has undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period
* Subject may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule
* Able and willing to provide informed consent

Exclusion Criteria:

* Prior history of diagnosed lung cancer
* History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years
* Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis)
* Immunosuppressive medication
* Deemed not able to participate in the study by the investigator

Where this trial is running

Atlanta, Georgia and 7 other locations

• Northside Hospital — Atlanta, Georgia, United States (Recruiting)
• Mass General Brigham — Boston, Massachusetts, United States (Recruiting)
• Henry Ford Health — Detroit, Michigan, United States (Recruiting)
• Jacobi Medical Center — Bronx, New York, United States (Recruiting)
• New York Health + Hospitals — Bronx, New York, United States (Recruiting)
• Duke University Health System — Durham, North Carolina, United States (Recruiting)
• Baptist Hospitals of Southeast Texas — Beaumont, Texas, United States (Recruiting)
• University Of Utah Health — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Kaja Tikk

Conditions Lung Cancer