Clinical Trials

Clinical Trials

Clinical Trial Number: BOSTON II
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Early Detection of Lung Cancer based on small RNA signatures

Study ID: BOSTON II
Phase N/A
Physician Investigator(s)
Study Locations

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484.476.2620
[email protected]

The purpose of this study is to see if a new test, called HBDx small RNA diagnostic test for lung cancer, can help diagnose people with lung cancer. The HBDx test has not been approved for sale by the U.S. Food and Drug Administration (FDA), therefore its use in this study is investigational.

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Eligibility Criteria

Inclusion criteria

To be eligible to participate in this study, an individual must meet all the following criteria:

  1. male and female patients, aged 50 to 80 years and meets the screening criteria
  2. 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
  3. undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period
  4. may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule
  5. and willing to provide informed consent

Exclusion criteria

A subject who meets any of the following criteria will be excluded from participation in this study:

  1. history of diagnosed lung cancer
  2. of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years
  3. infectious diseases, such blood borne viral diseases (e.g., HIV, HBV, HCV, or tuberculosis or any other Biosafety Level 3 (BSL III pathogen infections)
  4. medication
  5. not able to participate in the study by the investigator