NCT02297087

Next-generation Sequencing of Small Cell Lung Cancer to Identify Actionable Targets for Treatment

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Western Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim 1 - Launch Pilot Study. In this aim, the investigators seek to launch a pilot study and enroll 12 eligible patients with advanced small cell lung cancer (SCLC) and to obtain the necessary tumor biopsies to yield sufficient DNA and RNA for Genome-Wide Sequencing (GWS). Aim 2 - Treatment Selection. Completion of this study aim will provide a new clinical paradigm in the treatment of SCLC such that each individual patient would be treated with a single-agent or combination therapy of commercially available agents that relates to particular target(s) that have been identified via GWS.

Detailed description

Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant. Blood will be sent to Ashion for DNA extraction. Tumor specimens will be shipped to Ashion for DNA and RNA extraction. Ashion will process the samples for DNA and RNA Sequencing in their CLIA certified laboratory. A portion of the nucleic acid will be stored in Ashion and used to confirm actionable targets. Results will be submitted to the physician for possible inclusion in the treatment regimen. After sequencing analysis has been performed, a report will be provided to the treating oncologist. The PI and the treating oncologist may review the results to identify potential treatment. The treating oncologist may use this information at their discretion, and is not required to treat the patient based on the targets identified by the GWS analysis.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
GENETIC	Standard of care based on target(s) identified via GWS.

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2014-11-21
• Last updated: 2017-11-09

Locations

1 site across 1 country: United States