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Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

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ClinicalTrials.gov Identifier: NCT03116633
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Guardian Research Network, Inc.
Information provided by (Responsible Party):
Inivata

Study Description
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Brief Summary:
This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared with tissue biopsy in patients with advanced lung cancer

Condition or disease
Non-Small Cell Lung Cancer

Detailed Description:
The primary aim of this study is to investigate the concordance of Inivata liquid biopsy panel with standard tissue biopsy analysis for detecting genomic alterations in patients with advanced non-squamous non-small cell lung cancer (NSCLC).
Study Design
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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Multicenter Study to Evaluate the Performance and Utility of Inivata Liquid Biopsy Analysis Compared With Tissue Biopsy Analysis for Detection of Genomic Alterations in Patients With Lung Cancer
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort
Arm A
1st line setting-approx. 150 patients. collect tissue biopsy per standard of care & one blood draw (40ml)
Arm B
1st line setting- approx. 100 patients one blood draw (40ml)
Arm C
Approx. 10 patients tissue collection optional 3 blood draws (40ml) over 5 days


Outcome Measures
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Primary Outcome Measures :
  1. Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis. [ Time Frame: 12 months ]
    The primary endpoint is concordance in detecting molecular abnormalities using Inivata liquid biopsy panel compared with detection using tissue biopsy analysis.


Secondary Outcome Measures :
  1. Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis [ Time Frame: 12 months ]
    Detection of sensitivity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis

  2. Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis [ Time Frame: 12 months ]
    Detection of specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis

  3. Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited versus that observed where tumour biopsy is achieved [ Time Frame: 12 months ]
    Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited (Quantity Not Sufficient) versus that observed where tumour biopsy is achieved.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
Criteria

Inclusion Criteria:

  • Written, signed and dated informed consent
  • Male & female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
  • Patients intended to initiate first-line treatment (Arms A and B)
  • Patients who plan to have or have had a recent tumor tissue biopsy taken as part of their standard of care (Arm A)
  • 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
  • Any history of metastatic cancer.
  • Previous malignancy in the last 2 years (except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix).
  • Patient with a severe acute or chronic medical or psychiatric condition or laboratory abnormality
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116633


Locations
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United States, Arkansas
Mercy Hospital Cancer Center/Clinical Research
Fort Smith, Arkansas, United States, 72903
United States, Missouri
Mercy Cancer Center
Joplin, Missouri, United States, 64804
Mercy Clinic
Springfield, Missouri, United States, 65804
United States, Oklahoma
Mercy Clinic Oncology & Hematology
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Lehigh Valley Health Networks
Allentown, Pennsylvania, United States, 18103
United States, South Carolina
Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Inivata
Guardian Research Network, Inc.
More Information
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Responsible Party: Inivata
ClinicalTrials.gov Identifier: NCT03116633    
Other Study ID Numbers: GRN-ALV
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inivata:
lung cancer
biopsy
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases