Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Grupo Gallego de Cancer de Pulmon
Collaborators:
AstraZeneca
Dynamic Solutions
Information provided by (Responsible Party):
Grupo Gallego de Cancer de Pulmon
ClinicalTrials.gov Identifier:
NCT01717105
First received: October 26, 2012
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
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.
| Condition |
|---|
|
Metastatic Non-Small-Cell Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Grupo Gallego de Cancer de Pulmon:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients) [ Time Frame: 1 day (First study visit) ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients) [ Time Frame: 1 day (Progression Visit) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
Tumor tissue Plasma samples
| Estimated Enrollment: | 225 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
metastatic non-small cell lung cancer
Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Outpatient consultation in oncology
Criteria
Inclusion Criteria:
Inclusion Criteria for patients´ screening:
- 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:
Inclusion Criteria for patients´ follow-up
- Patients with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).
Exclusion Criteria:
- Combined histology of non-small cell and small cell lung cancer.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717105
Locations
| Spain | |
| Complexo Hospitalario Arquitecto Marcide | |
| Ferrol, A Coruña, Spain, 15405 | |
| Hospital Clínico Universitario de Santiago de Compostela | |
| Santiago de Compostela, A Coruña, Spain, 15706 | |
| Complejo Hospitalario de Ourense | |
| Ourense, Orense, Spain, 32005 | |
| Hospital Xeral-Cíes | |
| Vigo, Pontevedra, Spain, 36204 | |
| Hospital Povisa | |
| Vigo, Pontevedra, Spain, 36211 | |
| Hospital do Meixoeiro | |
| Vigo, Pontevedra, Spain, 36200 | |
| Centro Oncologico de Galicia | |
| A Coruña, Spain, 15009 | |
| Lucus Augusti Hospital | |
| Lugo, Spain, 27004 | |
| Complexo Hospitalario de Pontevedra | |
| Pontevedra, Spain, 36071 | |
Sponsors and Collaborators
Grupo Gallego de Cancer de Pulmon
AstraZeneca
Dynamic Solutions
Investigators
| Study Director: | Sergio Vázquez Estévez, Doctor | Grupo Gallego de Cáncer de Pulmón (GGCP) |
More Information
No publications provided
| Responsible Party: | Grupo Gallego de Cancer de Pulmon |
| ClinicalTrials.gov Identifier: | NCT01717105 History of Changes |
| Other Study ID Numbers: | GGCP 048-10, GGC-CPN-2010-01 |
| Study First Received: | October 26, 2012 |
| Last Updated: | November 5, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Grupo Gallego de Cancer de Pulmon:
|
Non-small cell lung cancer (NSCLC) Epidermal growth factor receptor (EGFR) positive mutation |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Mitogens Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013