Non-Small Cell Lung CancerNCT03116633
Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy
An observational study of Non-Small Cell Lung Cancer, run by Inivata at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 34 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Jun 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Lehigh Valley Health Networks
Allentown, Pennsylvania, 18103
Mercy Hospital Cancer Center/Clinical Research
Fort Smith, Arkansas, 72903
Mercy Cancer Center
Joplin, Missouri, 64804
Mercy Clinic Oncology & Hematology
Oklahoma City, Oklahoma, 73120
Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, 29303
Mercy Clinic
Springfield, Missouri, 65804
About this study
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
This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared with tissue biopsy in patients with advanced lung cancer
Read the 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).
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- lung cancer, biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis
Detection of sensitivity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
Measured: 12 months
Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis
Detection of specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
Measured: 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
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start30 Jun 2017
- Primary completion31 May 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inivata
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guardian Research Network, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116633
- Sponsor's protocol ID
- GRN-ALV
- Status last verified
- May 2019
- First submitted
- 5 Apr 2017
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03116633
- Acronym / sponsor ID
- GRN-ALV
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- lung cancer, biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- InivataIndustry (pharma, biotech, devices)
- Collaborators
- Guardian Research Network, Inc.
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis
Time frame: 12 months
Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis
Time frame: 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
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Inivata at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.