NCT01717105

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

1.8 years

First QC Date

October 26, 2012

Last Update Submit

November 5, 2012

Conditions

Metastatic Non-Small-Cell Lung Cancer

Keywords

Non-small cell lung cancer (NSCLC)Epidermal growth factor receptor (EGFR) positive mutation

Outcome Measures

Primary Outcomes (1)

  • Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia

    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

    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)

    1 day (Screening Visit)

  • Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)

    1 day (First study visit)

  • Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients)

    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)

    From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up)

  • +3 more secondary outcomes

Study Arms (1)

metastatic non-small cell lung cancer

Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient consultation in oncology

You may qualify if:

  • 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 with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).

You may not qualify if:

  • Combined histology of non-small cell and small cell lung cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centro Oncologico de Galicia

A Coruña, A Coruña, 15009, Spain

Location

Complexo Hospitalario Arquitecto Marcide

Ferrol, A Coruña, 15405, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Lucus Augusti Hospital

Lugo, Lugo, 27004, Spain

Location

Complejo Hospitalario de Ourense

Ourense, Orense, 32005, Spain

Location

Complexo Hospitalario de Pontevedra

Pontevedra, Pontevedra, 36071, Spain

Location

Hospital do Meixoeiro

Vigo, Pontevedra, 36200, Spain

Location

Hospital Xeral-Cíes

Vigo, Pontevedra, 36204, Spain

Location

Hospital Povisa

Vigo, Pontevedra, 36211, Spain

Location

Biospecimen

Retention: NONE RETAINED

Tumor tissue Plasma samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sergio Vázquez Estévez, Doctor

    Grupo Gallego de Cáncer de Pulmón (GGCP)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2012

First Posted

October 30, 2012

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

ES(9)