Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

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: NCT03116633
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Guardian Research Network, Inc.
Information provided by (Responsible Party):
Inivata

Tracking Information
First Submitted Date April 5, 2017
First Posted Date April 17, 2017
Last Update Posted Date May 16, 2019
Actual Study Start Date June 30, 2017
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2017)
Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis. [ Time Frame: 12 months ]
The primary endpoint is concordance in detecting molecular abnormalities using Inivata liquid biopsy panel compared with detection using tissue biopsy analysis.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 11, 2017)
  • Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis [ Time Frame: 12 months ]
    Detection of sensitivity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
  • Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis [ Time Frame: 12 months ]
    Detection of specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
  • Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited versus that observed where tumour biopsy is achieved [ Time Frame: 12 months ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
Condition Non-Small Cell Lung Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 15, 2019)
34
Original Estimated Enrollment
 (submitted: April 11, 2017)
260
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03116633
Other Study ID Numbers GRN-ALV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Inivata
Study Sponsor Inivata
Collaborators Guardian Research Network, Inc.
Investigators Not Provided
PRS Account Inivata
Verification Date May 2019