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Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02906852
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Vector Oncology
Information provided by (Responsible Party):
Inivata

Study Description
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Brief Summary:
The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer.

Condition or disease
Non-Small Cell Lung Cancer

Detailed Description:

The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer. Once selected for the study and with full informed consent, patients will have a blood draw to allow the detection of cancer-related genomic alterations that are detectable within the blood sample. These results will be compared to results obtained from genomic profiling via standard tissue biopsy taken as part of routine care to help determine whether such 'liquid biopsies' can be used to guide treatments in future patients. The results of the liquid biopsy will not be used to guide treatment decisions in study participants.

In addition there is data-collection of treatments received for non small cell lung cancer and the response to these treatments during the first 6 months post tissue and blood analysis, though no additional visits or procedures are required for the patient beyond the initial blood draw.

Study Design
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Study Type : Observational
Actual Enrollment : 264 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study to Evaluate the Performance of Inivata Liquid Biopsy Analysis Compared With Standard Tissue Biopsy Analysis for Detection of Genomic Alterations in Patients With Advanced Non-small Cell Lung Cancer.
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Lung Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Concordance in the detection of molecular abnormalities using Inivata's liquid biopsy panel with detection using standard of care tissue biopsy analysis [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Detection: sensitivity and specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis [ Time Frame: 1 year ]
  2. Proportion of NSCLC patients eligible for targeted therapy based on liquid biopsy analysis as an evaluation of feasibility molecular stratification, compared to standard of care alone [ Time Frame: 1 year ]
  3. Progression free survival (PFS) rate over 6 months [ Time Frame: 1 year ]
  4. Overall survival (OS) rate over 6 months [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Relationship of clinical response to therapy with mutation allele frequency (MAF) cutoff in Inivata liquid biopsy assay [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
A 40ml blood sample will be taken, from which Plasma and ultimately DNA will be prepared.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC, who are intended to initiate first-line treatment according to standard guidelines, or having recently progressed on first-line EGFR or ALK directed therapy and being considered for further therapy.
Criteria

Inclusion Criteria:

  • Written, signed and dated informed consent to participate in the study must be given by the patient in accordance with 21 CFR Part 312, the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6, and applicable regulations, before completing any study-related procedures.
  • Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
  • Arms A and B: Patients intended to initiate first-line treatment according to standard guidelines. Note, a patient is eligible to receive sterotactic radiosurgery (no whole-brain radiotherapy). Arm C: Patients who are at a second-line treatment setting or greater may participate. Note, a patient may be included if they have metastatic brain lesions. Arms A, B, C: If enrolled in a treatment clinical trial, patients may also enroll in this study if all eligibility criteria are met.
  • Arm A only: Patients intended to initiate first-line treatment according to standard guidelines who plan to have or have had a recent tumor tissue biopsy taken for molecular profiling as part of their standard of care.
  • 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 (Arms A and B)
  • Patients who have any other prior metastatic or current second primary cancer (Arms A and B)
  • Patient who has a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906852


Locations
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Sponsors and Collaborators
Inivata
Vector Oncology
Investigators
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Principal Investigator: Ramaswamy Govindan, MD Washington University School of Medicine
Principal Investigator: Edward Kim, MD Atrium Health Levine Cancer Institute
Study Director: Clive Morris, MD Inivata
More Information
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Responsible Party: Inivata
ClinicalTrials.gov Identifier: NCT02906852    
Other Study ID Numbers: INI001
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms