Clinical trial NCT03116633: Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: lung cancer
biopsy
Lead sponsor: Inivata
Sponsor class: INDUSTRY
Collaborators: name: Guardian Research Network, Inc.
First posted: 2017-04-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis.
timeFrame: 12 months
Secondary outcomes:
measure: Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis
timeFrame: 12 months
measure: Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis
timeFrame: 12 months
measure: Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited versus that observed where tumour biopsy is achieved
timeFrame: 12 months
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Mercy Hospital Cancer Center/Clinical Research
state: Arkansas
city: Joplin
country: United States
facility: Mercy Cancer Center
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic
state: Missouri
city: Oklahoma City
country: United States
facility: Mercy Clinic Oncology & Hematology
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Health Networks
state: Pennsylvania
city: Spartanburg
country: United States
facility: Gibbs Cancer Center & Research Institute
state: South Carolina
Study officials:
References: