Recurrence Monitoring in NSCLC Using Circulating Tumor DNA

Scripps Translational Science Institute

Status: Unknown

Conditions: Non Small Cell Lung Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03878537

IRB-17-7057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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