Use of Liquid Biopsy to Reduce Time to Treatment for Patients With Advanced Nonsquamous Non-small Cell Lung Cancer Diagnosed at Outside Sites
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- TTT measured in days
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to determine if liquid biopsies will reduce time to begin treatment in participants with non-small cell lung cancer (NSCLC). A liquid biopsy is a test done on a sample of blood to look for cancer cells.
Detailed Description
Referred patients with newly diagnosed NSCLC who have not had genetic testing for targetable mutations will be considered for this study. The primary objective of this prospective study is to examine if using liquid biopsy can reduce time to treatment (TTT) in external participants with NSCLC. Secondary objectives examined will include time to actionable genetic testing results (ctDNA or tissue), rate of actionable biomarker discovery, and rate of appropriate guideline-directed therapy based upon testing results. A liquid biopsy is a test done on a sample of blood to look for cancer cells. A traditional biopsy, which requires tissue to be removed from the body, takes 14 days to be tested. A liquid biopsy takes 7 days which significantly shortens the TTT for those diagnosed with NSCLC. By studying this, doctors may be better able to determine if this will be beneficial and result in less time taken to treat cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with newly diagnosed, advanced nonsquamous NSCLC referred to the Cleveland Clinic Taussig Cancer Center from outside centers without prior testing results available for targetable genetic alterations
- •Plan to receive systemic therapy at the Cleveland Clinic, OR plan to receive systemic therapy at an outside site while maintaining either intermittent follow up at Cleveland Clinic or with electronic health record access through Care Everywhere.
Exclusion Criteria
- •Prior therapy for this diagnosis of NSCLC
- •Prior adequate molecular testing done for the current diagnosis of NSCLC
Outcomes
Primary Outcomes
TTT measured in days
Time Frame: An average of 30 days
TTT measured in days - TTT will be summarized using mean, SD, and range. One sample t-test will be used to compare observed TTT against the null (30 days).
Secondary Outcomes
- Time to actionable genetic testing results(An average of 30 days)
- Rate of appropriate guideline-directed therapy based upon testing results(An average of 30 days)
- Rate of actionable biomarker discovery(An average of 30 days)