Screening for High Frequency Malignant Disease

Overview

About this study

The purpose of this study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subjects aged 50-80 years at time of consent.
  • Increased risk of lung cancer defined by: at least 20 pack-year smoking history and currently smoke or have quit within the past 15 years.
  • Willing to consent to the investigational blood draw during index LDCT screening visit and before any invasive procedures or treatment for lung cancer diagnosis.
  • Willing to consent to a 1-year, 2-year and additional follow-up per protocol.

Exclusion Criteria:

  • Subject has not smoked for 15 or more years.
  • Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery.
  • Subjects undergoing diagnostic low-dose CT scan for investigation of symptoms.
  • Preexisting or history of lung cancer.
  • Previously diagnosed high-risk lung lesion.
  • History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).
  • Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs).
  • Currently receiving treatment for pneumonia.
  • Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
  • Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/23/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Brendon Colaco, M.B.B.S.

Contact us for the latest status

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available
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CLS-20549659

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