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Completed

NCT Number: NCT03116633

Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

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

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mercy Hospital Cancer Center/Clinical Research, Fort Smith, Arkansas, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Inivata

Industry

Collaborators

  • Guardian Research Network, Inc.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2017
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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