Non-small Cell Lung CancerNCT02644889
EGFR Mutation Detection From Advanced NSCLC Patient Tissue and Plasma in EGFR-TKI Treatment
An observational study of Non-small Cell Lung Cancer, run by GenoSaber.
Trial summary
This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage Ⅲ-Ⅳ NSCLC with EGFR mutations and who began a treatment by TKI .
Who may be able to join
- Age older than 18 years and under 75 years
- Histologically and cytologically proven non-small Cell Lung Cancer
- Clinical stages Ⅲ ~ Ⅳ
- Not receive any anti-tumor treatment
- Eastern cooperative oncology group performance status (ECOG PS) =1~2
- Estimated survival time more than 3 months
- EGFR-TKI treatment for first-line or second-line
- Voluntary to participate in this clinical trial and sign the consent form
Who cannot join
- Patients have received EGFR-TKI therapy before the study
- With other malignancy history in the recent 5 years before the study
- Pregnancy or breast feeding phase
- Inadequate samples for testing
- Follow-up compliance is poor
About this study
Official title: Epidermal Growth Factor Receptor (EGFR) Mutation Detection From Advanced Non-small Cell Lung Cancer Tissue and Plasma in Tyrosine Kinase Inhibitor (TKI) Treatment
This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Epidermal growth factor receptor(EGFR), NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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 |
|---|---|---|
| Patients advanced NSCLC EGFR mutated | This is an observational study, there is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EGFR Mutation Detection of FFPE and plasma samples
To evaluate the feasibility of plasma EGFR detection from non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs and evaluate the correlation of EGFR mutations and prognosis.
Measured: baseline
EGFR Mutation Detection of plasma samples for the following-up patients who take TKI.
In order to monitor the change of plasma EGFR mutation copy number.
Measured: From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2018 (estimated)
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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GenoSaber
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644889
- Sponsor's protocol ID
- EGFR2015-02
- Status last verified
- Nov 2015
- First submitted
- 28 Dec 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidermal Growth Factor Receptor (EGFR) Mutation Detection From Advanced Non-small Cell Lung Cancer Tissue and Plasma in Tyrosine Kinase Inhibitor (TKI) Treatment
- ClinicalTrials.gov ID
- NCT02644889
- Acronym / sponsor ID
- EGFR2015-02
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Epidermal growth factor receptor(EGFR), NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GenoSaberIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Nov 2018 (estimated)
- First posted
- 1 Jan 2016 (estimated)
- 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 has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients advanced NSCLC EGFR mutated | – | –This is an observational study, there is no intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage Ⅲ-Ⅳ NSCLC with EGFR mutations and who began a treatment by TKI .
Key inclusion criteria (8 listed)
- Age older than 18 years and under 75 years
- Histologically and cytologically proven non-small Cell Lung Cancer
- Clinical stages Ⅲ ~ Ⅳ
- Not receive any anti-tumor treatment
- Eastern cooperative oncology group performance status (ECOG PS) =1~2
Key exclusion criteria (5 listed)
- Patients have received EGFR-TKI therapy before the study
- With other malignancy history in the recent 5 years before the study
- Pregnancy or breast feeding phase
- Inadequate samples for testing
- Follow-up compliance is poor
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
EGFR Mutation Detection of FFPE and plasma samples
Time frame: baseline
To evaluate the feasibility of plasma EGFR detection from non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs and evaluate the correlation of EGFR mutations and prognosis.
EGFR Mutation Detection of plasma samples for the following-up patients who take TKI.
Time frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years
In order to monitor the change of plasma EGFR mutation copy number.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by GenoSaber.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
EGFR Mutation Detection of FFPE and plasma samples (time frame: baseline). The study lists 2 primary outcomes in all. 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 7 Jan 2016; AzTrials last refreshed its copy on 2 Nov 2026.