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Circulating Tumor DNA in Patients at High Risk for Lung Cancer

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ClinicalTrials.gov Identifier: NCT02715102
Recruitment Status : Terminated (Patient accrual was slow due to exclusion of patients with prior cancers)
First Posted : March 22, 2016
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Pathway Genomics

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.

Condition or disease
Cancer of the Lung Lung Cancer Lung Neoplasms Adenocarcinoma of the Lung Non Small Cell Carcinoma of the Lung Small Cell Carcinoma of the Lung

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.

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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : June 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017





Primary Outcome Measures :
  1. Percentage of patients with lung cancer who had a positive ctDNA result (true positive) [ Time Frame: 5 years ]
    ctDNA results will be correlated with pathology and subsequent clinical findings.


Secondary Outcome Measures :
  1. Percentage of patients who develop any cancer during the 5 years of follow-up [ Time Frame: 5 years ]
    ctDNA results will be correlated with pathology and subsequent clinical findings.

  2. Percentage of patients without lung cancer who had a positive ctDNA result (false positive) [ Time Frame: 5 years ]
    ctDNA results will be correlated with pathology and subsequent clinical findings.

  3. Percentage of patients with lung cancer who had a negative ctDNA result (false negative) [ Time Frame: 5 years ]
    ctDNA results will be correlated with pathology and subsequent clinical findings.

  4. Percentage of patients without lung cancer who had a negative ctDNA result (true negative) [ Time Frame: 5 years ]
    ctDNA results will be correlated with pathology and subsequent clinical findings.


Biospecimen Retention:   Samples With DNA
DNA will be extracted and run in the ctDNA assay. Patients will be asked to either consent or not to consent to having their DNA extracted from the original specimen and their clinical information kept for optional anonymized medical research in the future.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients scheduled to undergo a diagnostic or therapeutic bronchoscopy or thoracotomy by Dr. Robert McKenna.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715102


Locations
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United States, California
Cardiothoracic Outpatient Clinic, Providence Saint John's Health Center, 2121 Santa Monica Blvd.
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Pathway Genomics
Investigators
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Principal Investigator: Robert J. McKenna, M.D. Providence Saint John's Health Center
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Responsible Party: Pathway Genomics
ClinicalTrials.gov Identifier: NCT02715102    
Other Study ID Numbers: Pathway Genomics - 006
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Through presentations at scientific meetings and in the peer-reviewed medical literature.
Keywords provided by Pathway Genomics:
lung cancer
lung neoplasms
lung nodules
screening tests for cancer
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Adenocarcinoma of Lung
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms