Clinical Trials

IRB Study Number 21-494

Status Recruiting

Location Cleveland Clinic Main Campus

Institute Respiratory Institute

Description

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.

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)

AND

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

1. 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

1. 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:

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

Exclusion Criteria

All Subjects:

1. History of previous cancer or therapy for cancer within the year prior to enrollment
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