Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung
Status unconfirmed
Conditions studied: Lung Cancer
In brief
2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.
Key facts
- Study ID
- NCT05987189
- Run by
- Hummingbird Diagnostics
- People needed
- 2000
- Starts
- 2023-10-18
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-01-16
Who can join
Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Northside Hospital — Atlanta, Georgia, United States (enrolling)
- Mass General Brigham — Boston, Massachusetts, United States (enrolling)
- Henry Ford Health — Detroit, Michigan, United States (enrolling)
- Jacobi Medical Center — The Bronx, New York, United States (enrolling)
- New York Health + Hospitals — The Bronx, New York, United States (enrolling)
- Duke University Health System — Durham, North Carolina, United States (enrolling)
- Baptist Hospitals of Southeast Texas — Beaumont, Texas, United States (enrolling)
- University Of Utah Health — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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