Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung
NCT ID: NCT05987189
Last Updated: 2024-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2023-10-18
2025-12-31
Brief Summary
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Detailed Description
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Study duration: Expected patient enrollment to be completed within 12 months after study initiation. Patients will be followed for a minimum of 12 months from the date of enrollment. The study duration is approximately 2 years.
Participant duration: The day of blood collection. Participants will follow their regular standard of care schedule as recommended by existing guidelines; no extra visits are planned. Follow up data will be obtained from the electronic medical record within at least 12 months of follow-up period.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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miLungDx
At study enrollment a blood sample will be drawn prior to any invasive diagnostic study or treatment. On this blood sample a novel lung cancer test relying on small RNA signatures will be performed and evaluated.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
No
Sponsors
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Hummingbird Diagnostics
INDUSTRY
Responsible Party
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Locations
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Northside Hospital
Atlanta, Georgia, United States
Mass General Brigham
Boston, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
Jacobi Medical Center
The Bronx, New York, United States
New York Health + Hospitals
The Bronx, New York, United States
Duke University Health System
Durham, North Carolina, United States
Baptist Hospitals of Southeast Texas
Beaumont, Texas, United States
University Of Utah Health
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Samantha Blevins
Role: primary
Sarah Morris
Role: backup
Other Identifiers
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Boston II
Identifier Type: -
Identifier Source: org_study_id
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