Circulating Tumor DNA in Patients at High Risk for Lung Cancer

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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