Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-30

Study Completion Date

2018-12-31

Brief Summary

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This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared with tissue biopsy in patients with advanced lung cancer

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Detailed Description

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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).

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm A

1st line setting-approx. 150 patients. collect tissue biopsy per standard of care \& one blood draw (40ml)

No interventions assigned to this group

Arm B

1st line setting- approx. 100 patients one blood draw (40ml)

No interventions assigned to this group

Arm C

Approx. 10 patients tissue collection optional 3 blood draws (40ml) over 5 days

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No