- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02762877
Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer
November 9, 2020 updated by: Genomic Health®, Inc.
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)
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)
Study Overview
Status
Terminated
Conditions
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.
Study Type
Observational
Enrollment (Actual)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Santiago, Chile, 7500691
- Instituto Nacional del tórax
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Santiago, Chile, 7500836
- Fundacion Arturo Lopez Perez
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Santiago, Chile, 7650551
- Clinica Alemana de Santiago
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Bordeaux, France, 33000
- Polyclinique Bordeaux Nord Aquitaine
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Cedex 1
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Clermont-Ferrand, Cedex 1, France, 63011
- Centre Jean Perrin
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Cedex 20
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Marseille, Cedex 20, France, 13915
- Hopital Nord
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Elm Park
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Dublin, Elm Park, Ireland, 4
- St. Vincent's University Hospital
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Shinjuku-ku
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Tokyo, Shinjuku-ku, Japan, 160-0023
- Tokyo Medical University Hospital
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Tsukiji, Chuo-ku
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Tokyo, Tsukiji, Chuo-ku, Japan, 104-0045
- National Cancer Center
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Oviedo, Spain, 33011
- Hospital Universitario Central Asturias
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocío
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Zaragosa, Spain, 50009
- Hospital Clinico Universitario Lozano Blesa
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Wirral
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Bebington, Wirral, United Kingdom, CH63 4JK
- Clatterbridge Cancer Center NHS Foundation Trust
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California
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Torrance, California, United States, 90277
- Cancer Care Associates d/b/a Torrance Memorial Physician Network
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Georgia
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Macon, Georgia, United States, 31201
- Central Georgia Cancer Care
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute
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New Jersey
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Belleville, New Jersey, United States, 07109
- Essex Oncology of North Jersey
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Neptune, New Jersey, United States, 07753
- Meridian Hospitals
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Ohio
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Canton, Ohio, United States, 44718
- Gabrail Cancer Center
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Tennessee
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Germantown, Tennessee, United States, 38138
- West Clinic
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Virginia
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Midlothian, Virginia, United States, 23114
- Bon Secours Cancer Institute
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Washington
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Tacoma, Washington, United States, 98405
- MultiCare Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Non small cell lung cancer patients
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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A
Patients with non-squamous NSCLC either newly diagnosed or progressing on any therapy (except erlotinib, gefitinib, or afatinib)
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B
Patients with non-squamous NSCLC who are progressing on erlotinib, gefitinib, or afatinib
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Concordance of Genomic Alterations in EGFR Detected in Plasma Versus Tumor Tissue in Stage IV Non Squamous NSCLC Patients Who Are Newly Diagnosed or Progressing on Treatment
Time Frame: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
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Assess concordance of genomic alterations in EGFR detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne, or locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.
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Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue.
Time Frame: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
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Assess concordance of genomic alterations in ALK (EML4-ALK fusions) detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne OR locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.
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Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
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Percentage of Participants With EGFR T790M Alterations in Plasma in Patients Progressing on EGFR Targeting Therapy (Erlotinib, Gefitinib, Afatinib).
Time Frame: Time between patient tumor tissue biopsy and and blood collection (blood collected after the patient progressed on EGFR targeted therapy)
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Detection of EGFR T790M alterations in plasma using the OncotypeSEQ Liquid Select assay.
Progression on EGFR targeting therapy (erlotinib, gefitinib, afatinib) assessed clinically or radiologically
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Time between patient tumor tissue biopsy and and blood collection (blood collected after the patient progressed on EGFR targeted therapy)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (ACTUAL)
July 1, 2018
Study Completion (ACTUAL)
June 19, 2019
Study Registration Dates
First Submitted
April 29, 2016
First Submitted That Met QC Criteria
May 3, 2016
First Posted (ESTIMATE)
May 5, 2016
Study Record Updates
Last Update Posted (ACTUAL)
November 17, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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