Lung Cancer Clinical Trial

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

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)

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Subjects must be 18 years or older.
Patients with stage IV non squamous NSCLC who are either newly diagnosed or progressing on any treatment (progression defined as increasing tumor size or new metastatic lesions on clinical or imaging assessment).
Patients with available tissue sample from a metastatic site or, if the patient presents with stage IV disease at diagnosis, from the primary tumor or a metastatic site. If a patient is progressing on EGFR targeted therapy (erlotinib, gefitinib, afatinib), tumor tissue sample is required only if available.
No new systemic anti-tumor therapy administered in the interval between the tissue biopsy and collection of the blood sample. (interval not to exceed eight weeks). Local radiation therapy is permitted.
Able and willing to read, understand and sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, or equivalent privacy law, where this is applicable.

Exclusion Criteria:

Patients who are currently receiving therapy (targeted, immune- or chemotherapy) without sign of progression.
Patients with squamous NSCLC.
Patients with more than 8 weeks between collection of tumor specimen and collection of blood sample for analysis. (Not applicable for patients progressing on EGFR targeted therapy with no biopsy at progression)
Patients changing EGFR therapy due to toxicity or preference without documented disease progression.
Patients progressing on Osimertinib treatment.
Patients with brain metastases only.
Inability to comply with study and/or follow-up procedures.
Unable or unwilling to provide written informed consent.

Study is for people with:

Lung Cancer

Estimated Enrollment:

140

Study ID:

NCT02762877

Recruitment Status:

Terminated

Sponsor:

Genomic Health®, Inc.

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There are 22 Locations for this study

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Cancer Care Associates d/b/a Torrance Memorial Physician Network
Torrance California, 90277, United States
Central Georgia Cancer Care
Macon Georgia, 31201, United States
Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
Essex Oncology of North Jersey
Belleville New Jersey, 07109, United States
Meridian Hospitals
Neptune New Jersey, 07753, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
West Clinic
Germantown Tennessee, 38138, United States
Bon Secours Cancer Institute
Midlothian Virginia, 23114, United States
MultiCare Health System
Tacoma Washington, 98405, United States
Instituto Nacional del Torax
Santiago , 75006, Chile
Fundación Arturo López Perez
Santiago , 75008, Chile
Clinica Alemana de Santiago
Santiago , 76505, Chile
Centre Jean Perrin
Clermont-Ferrand Cedex 1, 63011, France
Hôpital Nord
Marseille Cedex 20, 13915, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux , 33000, France
St. Vincent's University Hospital
Dublin Elm Park, 4, Ireland
Tokyo Medical University Hospital
Tokyo Shinjuku-ku, 160-0, Japan
National Cancer Center
Tokyo Tsukiji, Chuo-ku, 104-0, Japan
Hospital Universitario Central Asturias
Oviedo , 33011, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragosa , 50009, Spain
Clatterbridge Cancer Center NHS Foundation Trust
Bebington Wirral, CH63 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

140

Study ID:

NCT02762877

Recruitment Status:

Terminated

Sponsor:


Genomic Health®, Inc.

How clear is this clinincal trial information?

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