DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study) (NCT04825834) | Clinical Trial Compass
CompletedNot Applicable
DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)
United States2,992 participantsStarted 2021-03-22
Plain-language summary
The primary objective of this study, DELFI-L101, is to train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Ability to understand and provide written informed consent
ā. Age ā„ 50 years
ā. Current or Former Smoker
ā. ā„ 20 pack-years (pack years = number of packs per day X number of years smoked)
ā. Prior thoracic imaging with computed tomography (CT) within 12 months of enrollment (CT imaging for lung cancer screening for participants meeting inclusion criteria 6a and 6b; or CT imaging for lung cancer screening or diagnostic CT for participants meeting inclusion criteria 6c)
ā. Meet one of the criteria below:
ā. No suspected or confirmed lung cancer diagnosis OR
ā. Suspected of lung cancer OR
Exclusion criteria
ā. 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)
ā. Any history of hematologic malignancies or myelodysplasia
ā. Any history of organ tissue transplantation
ā. Any history of blood product transfusion
ā. Current pregnancy
What they're measuring
1
Accuracy of lung cancer detection measured by sensitivity, specificity, and the AUC of the ROC.
. Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
ā. Prior systemic therapy, definitive therapy, radiation, or surgical resection for the enrollment cancer diagnosis (with the exception of organ biopsies or surgery for non-melanoma skin cancer are not exclusionary)