Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing

Completed

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02906852

Run by

Inivata

People needed

264

Starts

2016-08-01

Expected to finish

2018-12-31

Last updated by the study team

2019-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Facey Medical Foundation — Mission Hills, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Eastern CT Hematology Oncology — Norwich, Connecticut, United States
• Christiana Care Health Services Inc — Newark, Delaware, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Mid-Florida Hematology and Oncology Centers — Orange City, Florida, United States
• Swedish Covenant Hospital — Chicago, Illinois, United States
• Edward M Kaplan, MD & Associates — Skokie, Illinois, United States
• Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States
• Norton Healthcare Inc — Louisville, Kentucky, United States
• Christus Cancer Treatment Center — Shreveport, Louisiana, United States
• Berkshire Hematology Oncology Services — Pittsfield, Massachusetts, United States
• Henry Ford Allegiance Health — Jackson, Michigan, United States
• Park Nicolett — Saint Louis Park, Minnesota, United States
• Jackson Oncology Associates, PLLC — Jackson, Mississippi, United States
• Boone Hospital Center — Columbia, Missouri, United States
• Washington University (St. Louis) — St Louis, Missouri, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Northshore Hematology Oncology — East Setauket, New York, United States
• Northern Westchester Hospital Association — Mount Kisco, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• Levine Cancer Center — Mint Hill, North Carolina, United States
• Pinehurst Medical Clinic — Pinehurst, North Carolina, United States
• Trinity Cancer Center — Minot, North Dakota, United States
• Providence Health and Services — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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