Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

NCT03116633 | Completed

• 1 other identifier: GRN-ALV
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 6

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

Conditions

Non-Small Cell Lung Cancer

Keywords

lung cancer; biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis

  12 months

• Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis

  12 months

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Inivata: lead
• Guardian Research Network, Inc.: collaborator

Study Sites (6)

Mercy Hospital Cancer Center/Clinical Research

Fort Smith, Arkansas, 72903, United States

Location

Mercy Cancer Center

Joplin, Missouri, 64804, United States

Location

Mercy Clinic

Springfield, Missouri, 65804, United States

Location

Mercy Clinic Oncology & Hematology

Oklahoma City, Oklahoma, 73120, United States

Location

Lehigh Valley Health Networks

Allentown, Pennsylvania, 18103, United States

Location

Gibbs Cancer Center & Research Institute

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 17, 2017
• Study Start: June 30, 2017
• Primary Completion: May 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)