Brief Title
Circulating Tumor DNA in Patients at High Risk for Lung Cancer
Official Title
Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for Detection of Lung Cancer in Patients Undergoing Diagnostic or Therapeutic Bronchoscopy or Thoracotomy
Brief Summary
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.
Detailed Description
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.
Study Type
Observational
Primary Outcome
Percentage of patients with lung cancer who had a positive ctDNA result (true positive)
Secondary Outcome
Percentage of patients who develop any cancer during the 5 years of follow-up
Condition
Cancer of the Lung
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
39
Start Date
June 2016
Completion Date
August 2017
Primary Completion Date
August 2017
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Robert J. McKenna, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02715102
Organization ID
Pathway Genomics - 006
Responsible Party
Sponsor
Study Sponsor
Pathway Genomics
Study Sponsor
Robert J. McKenna, M.D., Principal Investigator, Providence Saint John's Health Center
Verification Date
August 2017