Recurrence Monitoring in NSCLC Using Circulating Tumor DNA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Scripps Translational Science Institute
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Progression Free Survival
- Last Updated
- 5 years ago
Overview
Brief Summary
This research study is investigating the role of cell free tumor DNA profiling in determining disease relapse and/or progression for patients with advanced NSCLC.
Detailed Description
The objective of this study is to determine the ability of cell free tumor DNA genomic profiling to predict disease relapse or progression while on therapy for advanced stage NSCLC in comparison to current standard objective measures of disease relapse or progression. This study is a prospective observational study. The investigators will assess whole genome sequencing from patient blood samples collected alongside routine blood draws with each treatment cycle to determine the tumor load score at each timepoint while on therapy. CT images will be obtained at routinely ordered timepoints throughout therapy and will be used in the assessment for standard clinical or radiographic evidence of disease progression. These methods of measuring disease progression will be compared in a lead time analysis.
Investigators
Aditya Sarvaria, MD
Investigator
Scripps Translational Science Institute
Eligibility Criteria
Inclusion Criteria
- •Treatment naïve biopsy confirmed not surgically resectable stage III or greater NSCLC
- •Baseline CT imaging available
Exclusion Criteria
- •Patients unable to undergo biopsy for initial tissue diagnosis
- •Patients who do not wish to pursue standard of care therapy
- •Patients with another diagnosis of malignancy
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 24 months
Clinical or radiographic based PFS