Non Small Cell Lung CancerNCT02661009
Human EGFR Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
An observational study of Non Small Cell Lung Cancer and EGFR-TKI Resistant Mutation, run by GenoSaber.
Trial summary
In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical performance of the EGFR quantitative kits. 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer, EGFR-TKI Resistant Mutation, EGFR-TKI Sensitizing Mutation
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Sep 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non Small Cell Lung Cancer(stage Ⅲ-Ⅳ)
Who may be able to join
- 18~80 years old
- Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
- Did not receive any anti-tumor treatment.
- Sufficient samples for analysis
- 18~80 years old
- Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
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- At least one measurable focus
- With EGFR-TKI treatment
- Complete follow-up information after EGFR-TKI treatment
- Sufficient samples for analysis
Who cannot join
- Female patients of childbearing potential who are nursing or are pregnant.
- Samples are collected after patients receiving anti-tumor treatment.
- The plasma sample hemolysis.
- Tumor cells are not found in FFPE samples.
- Incomplete information of subjects
- predicting clinical efficacy group:
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- FFPE samples are collected after EGFR-TKI treatment.
- Female patients of childbearing potential who are nursing or are pregnant.
- Tumor cells are not found in FFPE samples.
- Incomplete information of subjects
About this study
Official title: Human EGFR(Epidermal Growth Factor Receptor) Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical performance of the EGFR quantitative kits.
- methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods.
- analysis of the relationship between the type and proportion of EGFR sensitive mutation and EGFR-TKI benefit.
Read the detailed description
According to the types of samples and the purpose of the study, the research consists of two groups: plasma and tissue matching group and predicting clinical efficacy group. The samples of the plasma and tissue matching group are the same period plasma and matched FFPE(formalin-fixed paraffin-embedded tissue)samples which will be collected before the first time patients accept any anti-tumor treatment. The samples of predicting clinical efficacy group are FFPE samples which will be collected before the patients receive EGFR-TKI treatment. In addition, the subjects have the complete prognostic follow-up data.
- Keywords
- NSCLC, EGFR, EGFR-TKI, PCR
- 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 |
|---|---|---|
| Plasma and tissue matching | Not described | |
| predicting clinical efficacy | Not described |
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 by Human EGFR Mutations Quantitative Detection Kit
Each subject will be collected 3-10 FFPE samples and 3 ml plasma samples.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016 (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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GenoSaber
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Sun Yat-sen University, Shanghai Chest Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661009
- Sponsor's protocol ID
- EGFR2015-01
- Status last verified
- Dec 2015
- First submitted
- 18 Jan 2016
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human EGFR(Epidermal Growth Factor Receptor) Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
- ClinicalTrials.gov ID
- NCT02661009
- Acronym / sponsor ID
- EGFR2015-01
- Keywords
- NSCLC, EGFR, EGFR-TKI, PCR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- GenoSaberIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Sun Yat-sen University, Shanghai Chest Hospital
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (estimated)
- First posted
- 21 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.
In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical performance of the EGFR quantitative kits.
- methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods.
- analysis of the relationship between the type and proportion of EGFR sensitive mutation and EGFR-TKI benefit.
Detailed description
According to the types of samples and the purpose of the study, the research consists of two groups: plasma and tissue matching group and predicting clinical efficacy group. The samples of the plasma and tissue matching group are the same period plasma and matched FFPE(formalin-fixed paraffin-embedded tissue)samples which will be collected before the first time patients accept any anti-tumor treatment. The samples of predicting clinical efficacy group are FFPE samples which will be collected before the patients receive EGFR-TKI treatment. In addition, the subjects have the complete prognostic follow-up data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma and tissue matching | – | – |
| predicting clinical efficacy | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non Small Cell Lung Cancer(stage Ⅲ-Ⅳ)
Key inclusion criteria (10 listed)
- 18~80 years old
- Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
- Did not receive any anti-tumor treatment.
- Sufficient samples for analysis
- 18~80 years old
Key exclusion criteria (10 listed)
- Female patients of childbearing potential who are nursing or are pregnant.
- Samples are collected after patients receiving anti-tumor treatment.
- The plasma sample hemolysis.
- Tumor cells are not found in FFPE samples.
- Incomplete information of subjects
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 by Human EGFR Mutations Quantitative Detection Kit
Time frame: 6 months
Each subject will be collected 3-10 FFPE samples and 3 ml plasma samples.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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 and EGFR-TKI Resistant Mutation, 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 10 inclusion and 10 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 21 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 by Human EGFR Mutations Quantitative Detection Kit (time frame: 6 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 21 Jan 2016; AzTrials last refreshed its copy on 29 Oct 2026.