Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03116633

Enrollment

Registered

2017-04-17

Start date

2017-06-30

Completion date

2018-12-31

Last updated

2019-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

lung cancer, biopsy

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis.	12 months	The primary endpoint is concordance in detecting molecular abnormalities using Inivata liquid biopsy panel compared with detection using tissue biopsy analysis.

Secondary

Measure	Time frame	Description
Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis	12 months	Detection of sensitivity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis	12 months	Detection of specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited versus that observed where tumour biopsy is achieved	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.

Countries

United States

Outcome results