Metastatic Non-Small-Cell Lung CancerNCT01717105
Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients
An observational study of Metastatic Non-Small-Cell Lung Cancer, run by Grupo Gallego de Cancer de Pulmon at 9 sites in Spain.
Trial summary
The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-Small-Cell Lung Cancer
- How many people
- 225 participants
- Where
- 9 sitesSpain
- Study dates
- Mar 2011to Feb 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: Outpatient consultation in oncology
Who may be able to join
- Patients of both sexes aged 18 or more.
- Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) (patients stage III B unsuitable for locoregional treatment, and stage IV).
- Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first line systemic cytotoxic chemotherapy).
- Patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.
- Patients who have granted their written informed consent.
- Patients must fulfill the inclusion criteria previously mentioned and the following one in order to be enrolled in the study (visit 1) for the follow-up until progression or until 9 months from the beginning of treatment have elapsed:
- Patients with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).
Who cannot join
- Combined histology of non-small cell and small cell lung cancer.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Centro Oncologico de Galicia
A Coruña, A Coruña, 15009
Complexo Hospitalario Arquitecto Marcide
Ferrol, A Coruña, 15405
Lucus Augusti Hospital
Lugo, Lugo, 27004
Complejo Hospitalario de Ourense
Ourense, Orense, 32005
Complexo Hospitalario de Pontevedra
Pontevedra, Pontevedra, 36071
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Hospital do Meixoeiro
Vigo, Pontevedra, 36200
Hospital Xeral-Cíes
Vigo, Pontevedra, 36204
Hospital Povisa
Vigo, Pontevedra, 36211
About this study
Official title: Observational Post-authorization Prospective Study to Characterize the Incidence of Epidermal Growth Factor Receptor (EGFR) Mutation Positive and Advanced Non-small Cell Lung Cancer Patients and Their Clinical Management in Galicia
The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.
- Conditions
- Metastatic Non-Small-Cell Lung Cancer
- Keywords
- Non-small cell lung cancer (NSCLC), Epidermal growth factor receptor (EGFR) positive mutation
- 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 |
|---|---|---|
| metastatic non-small cell lung cancer | Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia
Measured: 10 months (recruitment period)
Secondary outcomes (8)
Epidermal growth factor receptor (EGFR) mutational status in tumor tissue (primary tumor or metastatic samples) and plasma samples at screening
Measured: 1 day (Screening Visit)
Type of epidermal growth factor receptor (EGFR) mutations: deletion in exon 19, point mutation at codon 858 (L858R) or other (only for EGFR M+ patients)
Measured: 1 day (Screening Visit)
Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)
Measured: 1 day (First study visit)
Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients)
Measured: From inclusion until disease progression, death or until 9 months from the inclusion of the last patient in the study have elapsed, whichever is earlier.
Disease control (only for epidermal growth factor receptor (EGFR) M+ patients)
Measured: From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up)
Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients)
Measured: 1 day (Progression Visit)
Progression-free survival and overall survival (only for epidermal growth factor receptor (EGFR) M+ patients)
Measured: 1 day (at the end of the study 9 months subsequent to the last patient's inclusion or until lost of follow-up
Epidermal growth factor receptor (EGFR) mutational status at disease progression in tumor tissue (primary tumor or metastatic samples) and plasma samples (only for EGFR M+ patients)
Measured: 1 day (Progresion Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Gallego de Cancer de Pulmon
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Dynamic Solutions
- Responsible party
- Sponsor
- Investigators
- Sergio Vázquez Estévez, Doctor, Study director, Grupo Gallego de Cáncer de Pulmón (GGCP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717105
- Sponsor's protocol ID
- GGCP 048-10
- Other IDs
- GGC-CPN-2010-01
- Status last verified
- Nov 2012
- First submitted
- 26 Oct 2012
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Post-authorization Prospective Study to Characterize the Incidence of Epidermal Growth Factor Receptor (EGFR) Mutation Positive and Advanced Non-small Cell Lung Cancer Patients and Their Clinical Management in Galicia
- ClinicalTrials.gov ID
- NCT01717105
- Acronym / sponsor ID
- GGCP 048-10
- Conditions
- Metastatic Non-Small-Cell Lung Cancer
- Keywords
- Non-small cell lung cancer (NSCLC), Epidermal growth factor receptor (EGFR) positive mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Grupo Gallego de Cancer de PulmonUniversity, hospital or other
- Collaborators
- AstraZeneca, Dynamic Solutions
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 30 Oct 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 present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic non-small cell lung cancer | – | –Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient consultation in oncology
Key inclusion criteria (7 listed)
- Patients of both sexes aged 18 or more.
- Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) (patients stage III B unsuitable for locoregional treatment, and stage IV).
- Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first line systemic cytotoxic chemotherapy).
- Patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.
- Patients who have granted their written informed consent.
Key exclusion criteria (1 listed)
- Combined histology of non-small cell and small cell lung cancer.
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
Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia
Time frame: 10 months (recruitment period)
8 secondary outcomes
Epidermal growth factor receptor (EGFR) mutational status in tumor tissue (primary tumor or metastatic samples) and plasma samples at screening
Time frame: 1 day (Screening Visit)
Type of epidermal growth factor receptor (EGFR) mutations: deletion in exon 19, point mutation at codon 858 (L858R) or other (only for EGFR M+ patients)
Time frame: 1 day (Screening Visit)
Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)
Time frame: 1 day (First study visit)
Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients)
Time frame: From inclusion until disease progression, death or until 9 months from the inclusion of the last patient in the study have elapsed, whichever is earlier.
Disease control (only for epidermal growth factor receptor (EGFR) M+ patients)
Time frame: From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up)
Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients)
Time frame: 1 day (Progression Visit)
Progression-free survival and overall survival (only for epidermal growth factor receptor (EGFR) M+ patients)
Time frame: 1 day (at the end of the study 9 months subsequent to the last patient's inclusion or until lost of follow-up
Epidermal growth factor receptor (EGFR) mutational status at disease progression in tumor tissue (primary tumor or metastatic samples) and plasma samples (only for EGFR M+ patients)
Time frame: 1 day (Progresion Visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
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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.
Sergio Vázquez Estévez, Doctor study director
Grupo Gallego de Cáncer de Pulmón (GGCP)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Non-Small-Cell Lung Cancer, run by Grupo Gallego de Cancer de Pulmon at 9 sites in Spain.
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 7 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 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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?
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?
Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia (time frame: 10 months (recruitment period)). 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 6 Nov 2012.