Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing

NCT ID: NCT02906852

Last Updated: 2019-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

264 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vector Oncology

OTHER

Sponsor Role collaborator

Inivata

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ramaswamy Govindan, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Edward Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Levine Cancer Institute

Clive Morris, MD

Role: STUDY_DIRECTOR

Inivata

Locations

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Facey Medical Foundation

Mission Hills, California, United States

Site Status

University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status

Eastern CT Hematology Oncology

Norwich, Connecticut, United States

Site Status

Christiana Care Health Services Inc

Newark, Delaware, United States

Site Status

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Mid-Florida Hematology and Oncology Centers

Orange City, Florida, United States

Site Status

Swedish Covenant Hospital

Chicago, Illinois, United States

Site Status

Edward M Kaplan, MD & Associates

Skokie, Illinois, United States

Site Status

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Site Status

Norton Healthcare Inc

Louisville, Kentucky, United States

Site Status

Christus Cancer Treatment Center

Shreveport, Louisiana, United States

Site Status

Berkshire Hematology Oncology Services

Pittsfield, Massachusetts, United States

Site Status

Henry Ford Allegiance Health

Jackson, Michigan, United States

Site Status

Park Nicolett

Saint Louis Park, Minnesota, United States

Site Status

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

Site Status

Boone Hospital Center

Columbia, Missouri, United States

Site Status

Washington University (St. Louis)

St Louis, Missouri, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Northshore Hematology Oncology

East Setauket, New York, United States

Site Status

Northern Westchester Hospital Association

Mount Kisco, New York, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Levine Cancer Center

Mint Hill, North Carolina, United States

Site Status

Pinehurst Medical Clinic

Pinehurst, North Carolina, United States

Site Status

Trinity Cancer Center

Minot, North Dakota, United States

Site Status

Providence Health and Services

Portland, Oregon, United States

Site Status

Gettysburg Cancer Center

Gettysburg, Pennsylvania, United States

Site Status

Carolina Blood and Cancer Care

Rock Hill, South Carolina, United States

Site Status

The West Clinic

Germantown, Tennessee, United States

Site Status

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

Site Status

Thomas Spann Clinic Oncology

Corpus Christi, Texas, United States

Site Status

Hope Cancer Center of East Texas (Tyler Hem Onc)

Tyler, Texas, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Providence Regional Medical Center

Everett, Washington, United States

Site Status

University of Washington (Swedish General)

Seattle, Washington, United States

Site Status

Northwest Medical Specialties

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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INI001

Identifier Type: -

Identifier Source: org_study_id

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