Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT02906852
- Lead Sponsor
- Inivata
- Brief Summary
The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer.
- Detailed Description
The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer. Once selected for the study and with full informed consent, patients will have a blood draw to allow the detection of cancer-related genomic alterations that are detectable within the blood sample. These results will be compared to results obtained from genomic profiling via standard tissue biopsy taken as part of routine care to help determine whether such 'liquid biopsies' can be used to guide treatments in future patients. The results of the liquid biopsy will not be used to guide treatment decisions in study participants.
In addition there is data-collection of treatments received for non small cell lung cancer and the response to these treatments during the first 6 months post tissue and blood analysis, though no additional visits or procedures are required for the patient beyond the initial blood draw.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 264
- Written, signed and dated informed consent to participate in the study must be given by the patient in accordance with 21 CFR Part 312, the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6, and applicable regulations, before completing any study-related procedures.
- Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
- Arms A and B: Patients intended to initiate first-line treatment according to standard guidelines. Note, a patient is eligible to receive sterotactic radiosurgery (no whole-brain radiotherapy). Arm C: Patients who are at a second-line treatment setting or greater may participate. Note, a patient may be included if they have metastatic brain lesions. Arms A, B, C: If enrolled in a treatment clinical trial, patients may also enroll in this study if all eligibility criteria are met.
- Arm A only: Patients intended to initiate first-line treatment according to standard guidelines who plan to have or have had a recent tumor tissue biopsy taken for molecular profiling as part of their standard of care.
- Patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions.
- Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy (Arms A and B)
- Patients who have any other prior metastatic or current second primary cancer (Arms A and B)
- Patient who has a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concordance in the detection of molecular abnormalities using Inivata's liquid biopsy panel with detection using standard of care tissue biopsy analysis 1 year
- Secondary Outcome Measures
Name Time Method Detection: sensitivity and specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis 1 year Proportion of NSCLC patients eligible for targeted therapy based on liquid biopsy analysis as an evaluation of feasibility molecular stratification, compared to standard of care alone 1 year Progression free survival (PFS) rate over 6 months 1 year Overall survival (OS) rate over 6 months 1 year
Trial Locations
- Locations (35)
Thomas Spann Clinic Oncology
🇺🇸Corpus Christi, Texas, United States
Washington University (St. Louis)
🇺🇸Saint Louis, Missouri, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Park Nicolett
🇺🇸Saint Louis Park, Minnesota, United States
Norton Healthcare Inc
🇺🇸Louisville, Kentucky, United States
Henry Ford Allegiance Health
🇺🇸Jackson, Michigan, United States
Northshore Hematology Oncology
🇺🇸East Setauket, New York, United States
Christus Cancer Treatment Center
🇺🇸Shreveport, Louisiana, United States
Christiana Care Health Services Inc
🇺🇸Newark, Delaware, United States
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Eastern CT Hematology Oncology
🇺🇸Norwich, Connecticut, United States
Edward M Kaplan, MD & Associates
🇺🇸Skokie, Illinois, United States
Boone Hospital Center
🇺🇸Columbia, Missouri, United States
Swedish Covenant Hospital
🇺🇸Chicago, Illinois, United States
University of Washington (Swedish General)
🇺🇸Seattle, Washington, United States
Mid-Florida Hematology and Oncology Centers
🇺🇸Orange City, Florida, United States
Berkshire Hematology Oncology Services
🇺🇸Pittsfield, Massachusetts, United States
Gettysburg Cancer Center
🇺🇸Gettysburg, Pennsylvania, United States
Facey Medical Foundation
🇺🇸Mission Hills, California, United States
Northern Westchester Hospital Association
🇺🇸Mount Kisco, New York, United States
Hope Cancer Center of East Texas (Tyler Hem Onc)
🇺🇸Tyler, Texas, United States
Providence Regional Medical Center
🇺🇸Everett, Washington, United States
Jackson Oncology Associates, PLLC
🇺🇸Jackson, Mississippi, United States
Trinity Cancer Center
🇺🇸Minot, North Dakota, United States
Carolina Blood and Cancer Care
🇺🇸Rock Hill, South Carolina, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Pinehurst Medical Clinic
🇺🇸Pinehurst, North Carolina, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Levine Cancer Center
🇺🇸Mint Hill, North Carolina, United States
The West Clinic
🇺🇸Germantown, Tennessee, United States
Tennessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States
Providence Health and Services
🇺🇸Portland, Oregon, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States