Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT03116633
• Lead Sponsor: Inivata

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).

Study Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-17
• Study Start: 2017-06-30
• Primary Completion: 2018-05-31
• Study Completion: 2018-12-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Gibbs Cancer Center & Research Institute; 🇺🇸 Spartanburg, South Carolina, United States

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

Mercy Cancer Center; 🇺🇸 Joplin, Missouri, United States

Mercy Clinic; 🇺🇸 Springfield, Missouri, United States

Mercy Clinic Oncology & Hematology; 🇺🇸 Oklahoma City, Oklahoma, United States

Lehigh Valley Health Networks; 🇺🇸 Allentown, Pennsylvania, United States