Stage IIIB/IVIDENTIFYNCT01525199
Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.
An observational study of Stage IIIB/IV and Non-Small Cell Lung Cancer, run by AstraZeneca at 17 sites in Argentina.
Trial summary
The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIIB/IV, Non-Small Cell Lung Cancer
- How many people
- 450 participants
- Where
- 17 sitesArgentina
- Study dates
- May 2012to Nov 2013
- 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 will be recruited from specialized sites; all the participating investigators will be oncologists.
Who may be able to join
- Patients with confirmed diagnosis of lung adenocarcinoma, stage IIIb/IV.
- Patients under 1st line treatment against lung adenocarcinoma.
Who cannot join
- Patients not having the information required by the protocol.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Argentina17 sites
Research Site
Bahía Blanca, Buenos Aires
Research Site
Ciudad de Buenos Aires, Buenos Aires
Research Site
Córdoba, Córdoba Province
Research Site
Gral. Roca, Río Negro Province
Research Site
Junín, Buenos Aires
Research Site
La Plata, Buenos Aires
Research Site
La Rioja, La Rioja Province
Research Site
Lanus, Buenos Aires
Research Site
Lomas de Zamora, Buenos Aires
Research Site
Mar del Plata, Buenos Aires
Research Site
Mendoza, Mendoza Province
Research Site
Rosario, Santa Fe Province
Research Site
San Carlos de Bolivar, Buenos Aires
Research Site
San Luis, San Luis Province
Research Site
San Miguel de Tucumán, Tucumán Province
Research Site
Santa Fe, Santa Fe Province
Research Site
Santa Rosa, La Pampa Province
About this study
Official title: Study of Cases and Controls on Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.
The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. There is no assignment to any particular therapeutic strategy.
Read the detailed description
Study of cases and controls on diagnosis and treatment strategies in patients with NSCLC with or without EGFR mutations.
- Conditions
- Stage IIIB/IV, Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer,, Epidermal Growth Factor Receptor mutation,, Lung cancer,, Lung adenocarcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Adenocarcinoma of 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 |
|---|---|---|
| Case | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 12 months after the diagnosis of advanced disease
Overall Survival
Measured: 12 months after the diagnosis of advanced disease
Number of hospitalizations
Measured: 12 months after the diagnosis of advanced disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIB/IVStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525199
- Sponsor's protocol ID
- NIS-OAR-XXX-2011/1
- Acronym
- IDENTIFY
- Status last verified
- Apr 2014
- First submitted
- 31 Jan 2012
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cases and Controls on Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.
- ClinicalTrials.gov ID
- NCT01525199
- Acronym / sponsor ID
- IDENTIFY / NIS-OAR-XXX-2011/1
- Conditions
- Stage IIIB/IV, Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer,, Epidermal Growth Factor Receptor mutation,, Lung cancer,, Lung adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Feb 2012 (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.
The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. There is no assignment to any particular therapeutic strategy.
Detailed description
Study of cases and controls on diagnosis and treatment strategies in patients with NSCLC with or without EGFR mutations.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from specialized sites; all the participating investigators will be oncologists.
Key inclusion criteria (2 listed)
- Patients with confirmed diagnosis of lung adenocarcinoma, stage IIIb/IV.
- Patients under 1st line treatment against lung adenocarcinoma.
Key exclusion criteria (1 listed)
- Patients not having the information required by the protocol.
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
Disease free survival
Time frame: 12 months after the diagnosis of advanced disease
Overall Survival
Time frame: 12 months after the diagnosis of advanced disease
Number of hospitalizations
Time frame: 12 months after the diagnosis of advanced disease
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 14 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage IIIB/IV and Non-Small Cell Lung Cancer, run by AstraZeneca at 17 sites in Argentina.
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 2 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 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Argentina. 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?
Disease free survival (time frame: 12 months after the diagnosis of advanced disease). The study lists 3 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 14 Apr 2014.