Circulating Tumor DNA in Patients at High Risk for Lung Cancer

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02715102
• Other study ID #: Pathway Genomics - 006
• Status: Terminated
• Phase: N/A
• First received: March 14, 2016
• Last updated: August 16, 2017
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Pathway Genomics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Lung
• Cancer of the Lung
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Small Cell
• Lung Cancer
• Lung Neoplasms
• Non Small Cell Carcinoma of the Lung
• Small Cell Carcinoma of the Lung
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
United States	Cardiothoracic Outpatient Clinic, Providence Saint John's Health Center, 2121 Santa Monica Blvd.	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Pathway Genomics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with lung cancer who had a positive ctDNA result (true positive)	ctDNA results will be correlated with pathology and subsequent clinical findings.	5 years
Secondary	Percentage of patients who develop any cancer during the 5 years of follow-up	ctDNA results will be correlated with pathology and subsequent clinical findings.	5 years
Secondary	Percentage of patients without lung cancer who had a positive ctDNA result (false positive)	ctDNA results will be correlated with pathology and subsequent clinical findings.	5 years
Secondary	Percentage of patients with lung cancer who had a negative ctDNA result (false negative)	ctDNA results will be correlated with pathology and subsequent clinical findings.	5 years
Secondary	Percentage of patients without lung cancer who had a negative ctDNA result (true negative)	ctDNA results will be correlated with pathology and subsequent clinical findings.	5 years