Circulating Tumor DNA in Patients at High Risk for Lung Cancer
Circulating Tumor DNA in Patients at High Risk for Lung Cancer
Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic
 surgery without a distant history of cancer will have their blood drawn for measurement of
 circulating tumor DNA (ctDNA) to validate the utility of molecular diagnostic assays for the
 early detection of 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.