Non Small Cell Lung Cancer
Conditions
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.
Interventions
None listed
Sponsors
Scripps Health
Lexent Bio, Inc.
Scripps Translational Science Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 24 months | Cell free tumor DNA based PFS |
Countries
United States
Contacts
Primary ContactAditya Sarvaria
Backup ContactMarin Xavier
Outcome results
None listed