A Blood Based Assay for the Diagnosis of Early Stage Lung Cancer
This is a prospective study for the development and validation of blood based biomarkers for the diagnosis of early stage lung cancer. UT Southwestern is part of a consortium formed for the validation of blood biomarkers for lung cancer, and which has received notification of funding from the Department of Defense. Once approved, approximately 750 consented subjects suspected of having lung cancer but with out a confirmed diagnosis will have a blood sample taken. They will also be asked for access to their medical records so that they can be followed for a subsequent diagnosis of lung cancer. Subjects who are eventually diagnosed with lung cancer who undergo surgery for their disease will then have a leftover sample of their tumor tissue collected from pathology for further analysis. In addition to these subjects, approximately 100 subjects with known lung cancer will have a blood sample taken to act as control, bring the total protocol accrual to 850 subjects. This study will be conducted at two clinics at UT Southwestern (thoracic nodule evalution clinic at Parkland Health and Hospital Systems and a thoracic malignancy evaluation and therapy planning clinic at UTSW North Campus). This study will also be conducted at the Dallas Veteran and amp;apos;s Affairs Medical Center.
1. All patients being evaluated at the previously mentioned clinics for evaluation of lung cancer and whose status (cancer/cancer free) has not been determined.
2. Blood specimens will also be collected during years 1 and 2 from an additional 100 untreated subjects attending the previously mentioned clinics with a known diagnosis of lung cancer.
3. All races, ethnicities and genders will be allowed to enroll.
4. Spanish-speaking subjects will also be eligible for enrollment.