Status:
RECRUITING
Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung
Lead Sponsor:
Hummingbird Diagnostics
Conditions:
Lung Cancer
Eligibility:
All Genders
50-80 years
Brief Summary
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...
Detailed Description
The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. Study duration: Expected patient enrollment to be com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05987189
Start Date
October 18 2023
End Date
December 1 2025
Last Update
January 16 2024
Active Locations (8)
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1
Northside Hospital
Atlanta, Georgia, United States, 30342
2
Mass General Brigham
Boston, Massachusetts, United States, 02115
3
Henry Ford Health
Detroit, Michigan, United States, 48202
4
Jacobi Medical Center
The Bronx, New York, United States, 10461