NSCLCNCT01100827
A Retrospective Molecular Epidemiology Study in Singapore Patients With Advanced Non Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Histology to Assess Epidermal Growth Factor Receptor (EGFR) Mutation Status
An observational study of NSCLC, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
To determine EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC. To determine the association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- NSCLC
- What is being tested?
- EGFR mutation status in patients
- How many people
- Not given
- Where
- 1 siteSingapore
- Study dates
- Feb 2013to Feb 2015
- 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 1 year and older
- All sexes
- Child, Adult, Older adult
Study population: In order to determine the EGFR mutation status, data analysis will be performed on demographic data and medical records (i.e. case notes and pathology reports) from patient with advanced stage adenocarcinoma NSCLC
Who may be able to join
- Nil
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital Singapore
Singapore, Singapore
Ross Andrew Soo, MBBS, 65 6772 4624, ross_soo@nuhs.edu.sg
Ross Soo, MBBS
About this study
To determine EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC.
To determine the association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients.
- Conditions
- NSCLC
- Being tested
- EGFR mutation status in patients
- Keywords
- EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC, The association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR mutation status in patientsOther
| Study group | Role | What they receive |
|---|---|---|
| EGFR mutation status in patients | Not described Receives: Other: EGFR mutation status in patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100827
- Sponsor's protocol ID
- NS01/03/10
- Status last verified
- Dec 2013
- First submitted
- 7 Apr 2010
- Last updated
- 11 Dec 2013
- Results posted
- No
Publications
Shigematsu H, Lin L, Takahashi T, Nomura M, Suzuki M, Wistuba II, Fong KM, Lee H, Toyooka S, Shimizu N, Fujisawa T, Feng Z, Roth JA, Herz J, Minna JD, Gazdar AF. Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers. J Natl Cancer Inst. 2005 Mar 2;97(5):339-46. doi: 10.1093/jnci/dji055.
PubMed 15741570Miller VA, Kris MG, Shah N, Patel J, Azzoli C, Gomez J, Krug LM, Pao W, Rizvi N, Pizzo B, Tyson L, Venkatraman E, Ben-Porat L, Memoli N, Zakowski M, Rusch V, Heelan RT. Bronchioloalveolar pathologic subtype and smoking history predict sensitivity to gefitinib in advanced non-small-cell lung cancer. J Clin Oncol. 2004 Mar 15;22(6):1103-9. doi: 10.1200/JCO.2004.08.158.
PubMed 15020612
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Molecular Epidemiology Study in Singapore Patients With Advanced Non Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Histology to Assess Epidermal Growth Factor Receptor (EGFR) Mutation Status
- ClinicalTrials.gov ID
- NCT01100827
- Acronym / sponsor ID
- NS01/03/10
- Conditions
- NSCLC
- Keywords
- EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC, The association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients.
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 9 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.
To determine EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC.
To determine the association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGFR mutation status in patients | – | Other: EGFR mutation status in patients |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- In order to determine the EGFR mutation status, data analysis will be performed on demographic data and medical records (i.e. case notes and pathology reports) from patient with advanced stage adenocarcinoma NSCLC
Key inclusion criteria (1 listed)
- Nil
Key exclusion criteria (1 listed)
- Nil
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 |
|---|---|---|
| EGFR mutation status in patients | Other | EGFR mutation status in patients |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Background: PubMed 15741570Shigematsu H, Lin L, Takahashi T, Nomura M, Suzuki M, Wistuba II, Fong KM, Lee H, Toyooka S, Shimizu N, Fujisawa T, Feng Z, Roth JA, Herz J, Minna JD, Gazdar AF. Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers. J Natl Cancer Inst. 2005 Mar 2;97(5):339-46. doi: 10.1093/jnci/dji055.
- Background: PubMed 15020612Miller VA, Kris MG, Shah N, Patel J, Azzoli C, Gomez J, Krug LM, Pao W, Rizvi N, Pizzo B, Tyson L, Venkatraman E, Ben-Porat L, Memoli N, Zakowski M, Rusch V, Heelan RT. Bronchioloalveolar pathologic subtype and smoking history predict sensitivity to gefitinib in advanced non-small-cell lung cancer. J Clin Oncol. 2004 Mar 15;22(6):1103-9. doi: 10.1200/JCO.2004.08.158.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by National University Hospital, Singapore at 1 site in Singapore.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ross Andrew Soo, MBBS (65 6772 4624, ross_soo@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01100827, which also lists 2 linked publications.
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 11 Dec 2013.