A Study To Evaluate DNA Evaluation Of Fragments For Early Interception - Lung Cancer Training Study
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-006327
NCT ID: NCT04825834
Sponsor Protocol Number: DELFI-L101
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