Status:
COMPLETED
Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT
Lead Sponsor:
Hummingbird Diagnostics
Conditions:
Lung Cancer
Eligibility:
All Genders
55-80 years
Brief Summary
To demonstrate that the specificity of the Hummingbird microRNA profile for the diagnosis of lung cancer in a cohort of patients who meet current eligibility criteria for lung cancer screening in the ...
Detailed Description
This is a prospective, longitudinal, blinded, observational diagnostic study on 400 individuals undergoing lung cancer screening with low-dose computed tomography (LDCT). There will be two patient co...
Eligibility Criteria
Inclusion
- Subject is undergoing LDCT screening for lung cancer.
- Subject is 55 to 80 years of age.
- Subject has a minimum 30 pack-year smoking history.
- Subject has not quit smoking more than 15 years ago.
- Subject is without symptoms attributable to lung cancer.
- Subject is able and willing to provide informed consent.
Exclusion
- Subject has a history of lung, gastrointestinal, hematological, breast, thyroid, or genitourinary cancers within the past ten years.
- Subject is known to be infected with HIV, HBV, HCV, or tuberculosis or any other Biosafety Level 3 (BSL III) pathogen infections.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 15 2020
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT03452514
Start Date
November 1 2017
End Date
September 15 2020
Last Update
February 25 2021
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805