Recurrence Monitoring in NSCLC Using Circulating Tumor DNA

Non Small Cell Lung Cancer Clinical Trial

Official title:

Recurrence Monitoring in NSCLC Using Circulating Tumor DNA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03878537
• Other study ID #: IRB-17-7057
• Status: Recruiting
• Start date: March 14, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Scripps Translational Science Institute
• Contact: Aditya Sarvaria
• Phone: 619-849-4469
• Email: Sarvaria.Aditya[@]scripsshealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non Small Cell Lung Cancer
• Recurrence

Locations

Country	Name	City	State
United States	Scripps Health/Scripps Clinic Hillcrest/Scripps Clinic Torrey Pines	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	Lexent Bio, Inc., Scripps Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Cell free tumor DNA based PFS	24 months
Primary	Progression Free Survival	Clinical or radiographic based PFS	24 months