Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT

Completed

Conditions studied: Lung Cancer

In brief

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 U.S. is superior to the specificity of LDCT.

Key facts

Study ID

NCT03452514

Run by

Hummingbird Diagnostics

People needed

479

Starts

2017-11-01

Expected to finish

2020-09-15

Last updated by the study team

2021-02-25

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States

Full record on ClinicalTrials.gov

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