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)
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 17, 2020 · Source: ClinicalTrials.gov
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Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Genomic Health®, Inc.
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Cancer Care Associates d/b/a Torrance Memorial Physician NetworkTorrance, California
- Central Georgia Cancer CareMacon, Georgia
- Virginia Piper Cancer InstituteMinneapolis, Minnesota
- Essex Oncology of North JerseyBelleville, New Jersey
- Meridian HospitalsNeptune City, New Jersey
- Gabrail Cancer CenterCanton, Ohio
- West ClinicGermantown, Tennessee
- Bon Secours Cancer InstituteMidlothian, Virginia
- MultiCare Health SystemTacoma, Washington
- Instituto Nacional del ToraxSantiago
- Fundación Arturo López PerezSantiago
- Clinica Alemana de SantiagoSantiago
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 17, 2020. Always confirm current availability with the study team.