Non-Small Cell Lung CancerNCT02620657
Evaluate EGFR Mutation Status and Impact Factors in North China
An observational study of Non-Small Cell Lung Cancer, run by ying cheng.
Trial summary
Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria, will be recruited by 30 sites in North China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Non interventional study
- How many people
- 2,809 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to 8 Nov 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 3000 advanced NSCLC patients
Who may be able to join
- Histological or cytological confirmed NSCLC;
- Patients were diagnosed with advanced NSCLC from Jan 1st 2014 to Dec 31st 2014;
- Researchers should collect the records of consecutive NSCLC patients in each site.
Who cannot join
- Any patients without NSCLC diagnosis;
- Any patients which were diagnosed with advanced NSCLC before Jan 1st 2014 or after Dec 31st 2014.
About this study
Official title: A Retrospective Study on Real-world EGFR Mutation Testing Practice Status and Impact Factors in Patients With Advanced NSCLC in North China
Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria, will be recruited by 30 sites in North China.
Read the detailed description
Approximately 3000 advanced NSCLC patients will be recruited , and the medical information of recruited patients must be recorded in the hospital electronic system from Jan 1st 2014 to Dec 31st 2014 .The study will focus on the EGFR testing rate in adenocarcinoma patients，so the collecting data for non-adenocarcinoma patients will be controlled in less than 10% for each site.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Non interventional study
- 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.
Non interventional studyOther
Non interventional study
| Study group | Role | What they receive |
|---|---|---|
| Non interventional study | The patients with advanced NSCLC who have the medical records from Jan 1st 2014 to Dec 31st 2014 will be recruited . Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the proportion of advanced NSCLC patients who performed EGFR mutation test
Measured: 2014.01.01-2014.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion8 Nov 2017
- Study completion8 Nov 2017
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,809 participants (actual)
Sponsor and investigators
- Lead sponsor
- ying cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ying cheng, Guangdong Association of Clinical Trials
- Investigators
- CHENG NA Ying, Dr., Principal investigator, Jilin Provincial Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620657
- Sponsor's protocol ID
- 11224
- Status last verified
- Aug 2019
- First submitted
- 1 Dec 2015
- Last updated
- 2 Aug 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 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on Real-world EGFR Mutation Testing Practice Status and Impact Factors in Patients With Advanced NSCLC in North China
- ClinicalTrials.gov ID
- NCT02620657
- Acronym / sponsor ID
- 11224
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,809 participants (actual)
- Lead sponsor
- ying chengUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 3 Dec 2015 (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.
Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria, will be recruited by 30 sites in North China.
Detailed description
Approximately 3000 advanced NSCLC patients will be recruited , and the medical information of recruited patients must be recorded in the hospital electronic system from Jan 1st 2014 to Dec 31st 2014 .The study will focus on the EGFR testing rate in adenocarcinoma patients，so the collecting data for non-adenocarcinoma patients will be controlled in less than 10% for each site.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non interventional study | – | Other: Non interventional studyThe patients with advanced NSCLC who have the medical records from Jan 1st 2014 to Dec 31st 2014 will be recruited . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 3000 advanced NSCLC patients
Key inclusion criteria (3 listed)
- Histological or cytological confirmed NSCLC;
- Patients were diagnosed with advanced NSCLC from Jan 1st 2014 to Dec 31st 2014;
- Researchers should collect the records of consecutive NSCLC patients in each site.
Key exclusion criteria (2 listed)
- Any patients without NSCLC diagnosis;
- Any patients which were diagnosed with advanced NSCLC before Jan 1st 2014 or after Dec 31st 2014.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventional studyNon interventional study | Other | Non interventional study |
Primary outcome
To investigate the proportion of advanced NSCLC patients who performed EGFR mutation test
Time frame: 2014.01.01-2014.12.31
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 2 Aug 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.
CHENG NA Ying, Dr. principal investigator
Jilin Provincial Tumor Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by ying cheng.
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 3 inclusion and 2 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 2 Aug 2019. 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?
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?
To investigate the proportion of advanced NSCLC patients who performed EGFR mutation test (time frame: 2014.01.01-2014.12.31). 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 2 Aug 2019.