NCT02762877

Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer

A Study to Determine the Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma From Patients With Non Small Cell Lung Carcinoma (NSCLC)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Genomic Health®, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to determine the concordance of key actionable genomic alterations as assessed in tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)

Detailed description

This is a prospective clinical study to characterize the concordance of key clinically relevant genomic alterations in tumor tissue (biopsy/excision/cytology) and liquid biopsy (blood) using the Genomic Health LBMP in patients with stage IV non squamous NSCLC, that are either newly diagnosed with metastatic disease or progressing on therapy (any line). Tissue biopsy and blood collection (liquid biopsy) should be less than eight weeks apart and with no new systemic antitumoral treatment given in the interval between the tissue biopsy and blood collection. Local assessment of tumor tissue samples will be performed at each participating institution as per their clinical standard of care practices and results from the local assessment of genomic alteration status will be used.

Conditions

• Non Small Cell Lung Carcinoma

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-07-01
• Completion: 2019-06-19
• First posted: 2016-05-05
• Last updated: 2020-11-17
• Results posted: 2019-11-25

Locations

22 sites across 7 countries: United States, Chile, France, Ireland, Japan, Spain, United Kingdom