Screening for High Frequency Malignant Disease

Overview

About this study

The primary objective of the 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
* Undergoing or intended to undergo low dose CT scan of the chest for lung cancer screening
* 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 and additional follow-up per protocol

Exclusion Criteria:

1. Subject has quit smoking for 15 or more years
2. Subject has less than 20 pack-year smoking history
3. Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery
4. Subject undergoing low-dose CT scan of the chest for investigation of symptoms suspicious for lung cancer
5. Preexisting or history of lung cancer
6. Previously diagnosed high-risk lung lesion
7. 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)
8. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs
9. Currently receiving treatment for pneumonia
10. 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
11. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study
12. Participation in a clinical research study in which an experimental medication and/or medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening

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

Eligibility last updated 7/17/2024. 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

Rochester, Minn.

Mayo Clinic principal investigator

David Midthun, M.D.

Open for enrollment

Contact information:

Jodi Mahon

(507) 293-0694

Mahon.Jodi@mayo.edu

La Crosse, Wis.

Mayo Clinic principal investigator

Daniel Deetz, M.D.

Contact us for the latest status

Contact information:

Lindsey Bahr C.C.R.C.

(608) 392-9056

Bahr.Lindsey@mayo.edu

Eau Claire, Wis.

Mayo Clinic principal investigator

Ali Zaied, M.D.

Contact us for the latest status

Contact information:

Tasha Schneider

(715) 464-8172

Schneider.Tasha@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions