Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116633
• Other study ID #: GRN-ALV
• Status: Completed
• Start date: June 30, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2019
• Source: Inivata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
United States	Lehigh Valley Health Networks	Allentown	Pennsylvania
United States	Mercy Hospital Cancer Center/Clinical Research	Fort Smith	Arkansas
United States	Mercy Cancer Center	Joplin	Missouri
United States	Mercy Clinic Oncology & Hematology	Oklahoma City	Oklahoma
United States	Gibbs Cancer Center & Research Institute	Spartanburg	South Carolina
United States	Mercy Clinic	Springfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Inivata	Guardian Research Network, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis.	The primary endpoint is concordance in detecting molecular abnormalities using Inivata liquid biopsy panel compared with detection using tissue biopsy analysis.	12 months
Secondary	Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis	Detection of sensitivity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis	12 months
Secondary	Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis	Detection of specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis	12 months
Secondary	Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited versus that observed where tumour biopsy is achieved	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.	12 months