Circulating Tumor DNA in Patients at High Risk for Lung Cancer

Specific somatic (i.e. acquired and not inherited) mutations have been found in many
cancers. Some of these cancers shed this DNA into the patient's blood stream and is called
circulating tumor DNA (ctDNA). Pathway Genomics has developed a new molecular assay that
uses blood plasma as the source of DNA fragments. The ctDNA is isolated, amplified and
analyzed for the presence of one or more of 96 known mutations that are found in 9 cancer
driver genes. This technique of using a "liquid biopsy" to screen for and monitor cancer has
been documented in a number of recent medical publications. However, the majority of
published studies are on subjects who have already been diagnosed with cancer. Therefore,
the investigators wish to look at a population of patients who are scheduled to undergo a
diagnostic or therapeutic bronchoscopy or thoracotomy without a know history of cancer
(other than basal cell carcinomas of the skin). The blood will be drawn at the time of or a
few weeks before the procedure. The analysis of the blood sample will take placed in the
Pathway Genomics clinical laboratory which is Clinical Laboratory Improvement Amendments of
1988 (CLIA) certified.

Following an informed consent process, the patients will fill out a health questionnaire and
will have the blood drawn prior to the surgical procedure. Up to 30 ml of blood
(approximately 2 tablespoons) will be drawn at any one time. The patient will be asked to
agree to being contacted by the investigators yearly for up to 5 years to provide follow-up
medical information. No patient will be identified in presentations or publications
resulting from this work and all data will be reported from analysis of combined information
from participants in this study.

Individuals may participate in this study if they are 18 years of age or older, have not had
a prior diagnosis of cancer (other than a skin cancer or if they are undergoing the thoracic
surgical procedure for a cancer that was diagnosed within the prior month), and are
undergoing a diagnostic or therapeutic bronchoscopy or thoracotomy.

Inclusion Criteria:

- 18 years of age or older, not previously diagnosed with cancer (except for basal cell
carcinomas of the skin or a diagnosis of cancer within a month of surgery and for
which the surgical procedure is being performed).

Exclusion Criteria:

- Prior history of cancer.