Study Of Use Of Pemetrexed In Patients With Non-Small Lung Cancer Metastatic In Andalusian Public Health System

December 4, 2014 updated by: Fundación Pública Andaluza Progreso y Salud

STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM

STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Javier Bautista Paloma
  • Phone Number: 955 01 20 00

Study Contact Backup

Study Locations

  • Spain
      • Almería, Spain
        • Recruiting
        • Hospital Universitario Torrecárdenas
        • Contact:
          • Juan José Fernández Avila
      • Cádiz, Spain
        • Recruiting
        • Hospital Universitario Puerta del Mar
        • Contact:
          • María José Martínez Bautista
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • Ana Isabel Gago Sánchez
      • Granada, Spain
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
          • Inmaculada Vallejo Rodríguez
      • Granada, Spain
        • Recruiting
        • Hospital San Cecilio
        • Contact:
          • Miguel Damas Fernández Fijares
      • Granada, Spain
        • Recruiting
        • Hospital Santa Ana
        • Contact:
          • Marcos Camacho Romera
      • Huelva, Spain
        • Recruiting
        • Hospital Universitario Juan Ramón Jiménez
        • Contact:
          • Mª Teresa Garrido Martínez
      • Málaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Begoña Muros de Fuentes
      • Málaga, Spain
        • Recruiting
        • Hospital Regional De Malaga
        • Contact:
          • Beatriz Mora Rodríguez
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
          • Javier Bautista Paloma
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Nuria Muñoz Muñoz
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen de Valme
        • Contact:
          • Silvia Artecho
    • Cádiz
      • Algeciras, Cádiz, Spain
        • Recruiting
        • Hospital La Línea
        • Contact:
          • José Carlos Roldán
      • Algeciras, Cádiz, Spain
        • Recruiting
        • Hospital Punta de Europa
        • Contact:
          • Pablo Villanueva Jiménez
      • Jerez de la Frontera, Cádiz, Spain
        • Recruiting
        • Hospital Jerez de la Frontera
        • Contact:
          • Rocío Gavira Moreno
      • Marbella, Cádiz, Spain
        • Recruiting
        • Hospital Costa del Sol
        • Contact:
          • Margarita Garrido
      • Puerto Real, Cádiz, Spain
        • Recruiting
        • Hospital de Puerto Real
        • Contact:
          • Carmen Martínez Díaz
    • Granada
      • Baza, Granada, Spain
        • Recruiting
        • Hospital de Baza
        • Contact:
          • Francisco Nieto Cobo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

It will be included all patients diagnosed CPNMm participating centers to initiate treatment with pemetrexed in 1st line (either induction or maintenance.

Description

Inclusion Criteria:

  • Patients over 18 years
  • Confirmed diagnosis of metastatic NSCLC
  • Pemetrexed Starts 1st line (either induction or maintenance) in any of the following periods:
  • January 1, 2010 to March 31, 2010
  • October 1, 2011 to December 31, 2011

Exclusion Criteria:

  • Patients receiving pemetrexed within a clinical trial protocol because it is an experimental environment that does not reflect clinical practice.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Pemetrexed 500 mg/m 2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Determine utilization profile (line treatment and scheme used) of pemetrexed in patients with non-small cell lung cancer metastatic (CPNMm) in Andalusia.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
1) Determine the progression-free survival and overall survival 2) Evaluate the degree of adherence in prescribing pemetrexed patients with CPNMm in Andalusia approved indications, the recommendations of the Pharmacy and Therapeutics Committees and
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Pública Andaluza Progreso y Salud

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Javier Bautista Paloma, Hospitales Universitarios Virgen del Rocío

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FPS-PEM-2013-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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