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:

  • Ability to understand and provide written informed consent.
  • Age ≥ 50 years.
  • Current or former smoker.
  • ≥ 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:

  • 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
  • Meet one of the criteria below:
    • No suspected or confirmed lung cancer diagnosis as defined by:
    • No clinical and/or radiological findings that indicate suspicion of lung cancer diagnosis (i.e., no lung nodules, < 6mm lung nodules, or ≥ 6mm lung nodules with no change from prior CT scan); OR
    • Suspected of lung cancer as defined by:
    • Radiological finding and/or clinical evaluation that indicates suspicion of lung cancer diagnosis (i.e., suspicious lung nodule(s) ≥ 6mm or Lung-RADS 3/4 for first-time CT scan patients and newly suspicious lung nodule(s) ≥ 6mm or Lung-RADS 3/4 identified within 6 months prior to enrollment for follow-up and surveillance CT scan patients). Subjects must have not received therapy prior to blood collection; OR
    • Confirmed, untreated lung cancer as defined by:
    • Pathologic diagnosis of lung cancer with no prior systemic therapy, definitive therapy, radiation, or surgical resection for any lesion.

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

  • Pathologic confirmed, solid-tumor cancer diagnosis, that is not lung cancer or nonmelanoma skin cancer, with no prior systemic therapy, definitive therapy, radiation, or surgical resection.

Exclusion Criteria - All Subjects:

  • History of previous cancer or therapy for cancer within the year prior to enrollment.
  • Any history of hematologic malignancies or myelodysplasia.
  • Any history of organ tissue transplantation.
  • Any history of blood product transfusion within prior month.
  • Current pregnancy.
  • Any condition that in the opinion of the Investigator should preclude the subject’s participation in the study.

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.

Closed for enrollment

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

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