Circulating Tumor DNA in Patients at High Risk for Lung Cancer

NCT02715102 | Terminated

• 1 other identifier: Pathway Genomics - 006
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lung cancer; lung neoplasms; lung nodules; screening tests for cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of patients who develop any cancer during the 5 years of follow-up

  5 years

• Percentage of patients without lung cancer who had a positive ctDNA result (false positive)

  5 years

• Percentage of patients with lung cancer who had a negative ctDNA result (false negative)

  5 years

• Percentage of patients without lung cancer who had a negative ctDNA result (true negative)

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled to undergo a diagnostic or therapeutic bronchoscopy or thoracotomy by Dr. Robert McKenna.

You may qualify if:

• 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).

You may not qualify if:

• Prior history of cancer.

Sponsors & Collaborators

• Pathway Genomics: lead

Study Sites (1)

Cardiothoracic Outpatient Clinic, Providence Saint John's Health Center, 2121 Santa Monica Blvd.

Santa Monica, California, 90404, United States

Location

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.

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Robert J. McKenna, M.D.

  Providence Saint John's Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 22, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 21, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)