Non Small Cell Lung CancerNCT00956280
Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by AstraZeneca at 5 sites in Brazil.
Trial summary
The purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC). 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
- 100 participants
- Where
- 5 sitesBrazil
- Study dates
- Sep 2009to Apr 2010
- 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 with Advanced Non Small Cell Lung Cancer
Who may be able to join
- Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)
- Tumour sample (block of slides) available for KRAS analysis
Who cannot join
- Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.
- Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Research Site
Belo Horizonte
Research Site
Porto Alegre
Research Site
Rio de Janeiro
Research Site
Santo André
Research Site
São Paulo
About this study
The purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC).
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- The frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC, KRAS mutation in population with advanced NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyze the frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC.
Measured: March 31, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionApr 2010
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratorio Progenetica
- Investigators
- José Eduardo Pipolo das Neves, MD, Study director, AstraZeneca do Brasil, MC Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956280
- Sponsor's protocol ID
- NIS-OBR-DUM-2008/1
- Other IDs
- IMPACT 14829
- Status last verified
- May 2010
- First submitted
- 10 Aug 2009
- Last updated
- 13 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00956280
- Acronym / sponsor ID
- NIS-OBR-DUM-2008/1
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- The frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC, KRAS mutation in population with advanced NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Laboratorio Progenetica
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 11 Aug 2009 (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 study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Advanced Non Small Cell Lung Cancer
Key inclusion criteria (2 listed)
- Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)
- Tumour sample (block of slides) available for KRAS analysis
Key exclusion criteria (2 listed)
- Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.
- Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)
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
To analyze the frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC.
Time frame: March 31, 2010
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 13 May 2010.
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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.
José Eduardo Pipolo das Neves, MD study director
AstraZeneca do Brasil, MC Medical Director
5 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 5 sites in Brazil.
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 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 13 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. 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?
To analyze the frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC. (time frame: March 31, 2010). 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 13 May 2010.