Non-Small Cell Lung CancerICANNCT01106781
A Non-interventional Survey on the EGFR (Epidermal Growth Factor Receptor) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology
An observational study of Non-Small Cell Lung Cancer, run by AstraZeneca at 13 sites in China.
Trial summary
This is a descriptive observational study. The primary objective is to explore the EGFR gene mutation status in early stage NSCLC with adenocarcinoma histology after complete resection. 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
- 591 participants
- Where
- 13 sitesChina
- Study dates
- Aug 2010to Jan 2014
- 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: Patients from Thoracic surgery department
Who may be able to join
- Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
- Have completed lung cancer operation
- The tumour EGFR gene mutation status test was performed as regular medical practice
Who cannot join
- Patients who disagree to participate this study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Research Site
Beijing, Beijing Municipality
Research Site
Changchun, Jilin
Research Site
Chengdu, Sichuan
Research Site
Chongqing, Chongqing Municipality
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou, Zhejiang
Research Site
Nanjing, Jiangsu
Research Site
Qingdao, Shandong
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Suzhou, Jiangsu
Research Site
Tianjin, Tianjin Municipality
Research Site
Wuhan, Hubei
About this study
Official title: A Non-interventional Survey on the Epidermal Growth Factor Receptor (EGFR) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology
This is a descriptive observational study. The primary objective is to explore the EGFR gene mutation status in early stage NSCLC with adenocarcinoma histology after complete resection. The patients should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation in regular medical practice.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- EGFR mutation test, NSCLC, Non-Interventional Study, EGFR mutation status
- 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 |
|---|---|---|
| 1 | Patients in this group should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
type and prevalence of EGFR mutation
Measured: up to 3 months
Secondary outcomes (2)
Operation type and adjuvant treatment type
Measured: up to 3 months
Disease Free Survival rate
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2014
- Study completionJan 2014
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Atkin, Study director, Astrazeneca China R&DWu Yilong, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106781
- Sponsor's protocol ID
- NIS-OCN-DUM-2009/1
- Acronym
- ICAN
- Status last verified
- Mar 2014
- First submitted
- 14 Apr 2010
- Last updated
- 18 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Survey on the Epidermal Growth Factor Receptor (EGFR) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology
- ClinicalTrials.gov ID
- NCT01106781
- Acronym / sponsor ID
- ICAN / NIS-OCN-DUM-2009/1
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- EGFR mutation test, NSCLC, Non-Interventional Study, EGFR mutation status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Apr 2010 (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 is a descriptive observational study. The primary objective is to explore the EGFR gene mutation status in early stage NSCLC with adenocarcinoma histology after complete resection. The patients should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation in regular medical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients in this group should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Thoracic surgery department
Key inclusion criteria (3 listed)
- Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
- Have completed lung cancer operation
- The tumour EGFR gene mutation status test was performed as regular medical practice
Key exclusion criteria (1 listed)
- Patients who disagree to participate this study
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
type and prevalence of EGFR mutation
Time frame: up to 3 months
2 secondary outcomes
Operation type and adjuvant treatment type
Time frame: up to 3 months
Disease Free Survival rate
Time frame: up to 3 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 18 Mar 2014.
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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.
Karen Atkin study director
Astrazeneca China R&D
Wu Yilong principal investigator
Guangdong Provincial People's Hospital
13 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 AstraZeneca at 13 sites in China.
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 1 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 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. 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?
type and prevalence of EGFR mutation (time frame: up to 3 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 18 Mar 2014.