A Study to Evaluate DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study

Overview

About this study

The purpose of this study is train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features. 

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:

All Subjects:

1. Ability to understand and provide written informed consent

2. Age ≥ 50 years

3. Current or Former Smoker

4. ≥ 20 pack-years (pack years = number of packs per day X number of years smoked)

Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:

5. Prior thoracic imaging (computed tomography (CT)) within 12 months of enrollment OR
Planned thoracic imaging (CT) as part of standard of care within 6 weeks of enrollment

AND

6. Meet one of the criteria below:

1. No suspected or confirmed lung cancer diagnosis OR

2. Suspected of lung cancer OR

3. Confirmed, untreated lung cancer

Inclusion Group 2: High Risk Patients with cancer other than lung cancer that meet the
following criteria:

7. Pathologic confirmed, invasive cancer diagnosis, that is not lung cancer with no prior
systemic therapy, definitive therapy, radiation, or surgical resection.

Exclusion Criteria:

All Subjects:

1. Prior systemic therapy, definitive therapy, radiation, or surgical resection for
cancer within one year prior to enrollment (with the exception of organ biopsies or
surgery for non-melanoma skin cancer)

2. Any history of hematologic malignancies or myelodysplasia

3. Any history of organ tissue transplantation

4. Any history of blood product transfusion

5. Current pregnancy

6. Any condition that in the opinion of the Investigator should preclude the subject's
participation in the study

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

Eligibility last updated 11/16/22. 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

Rochester, Minn.

Mayo Clinic principal investigator

Dennis Wigle, M.D., Ph.D.

Open for enrollment

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

More information

Publications

Publications are currently not available
.

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