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Trial record 16 of 5021 for:    NSCLC

Prospective Observational Study To Identify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management (IDEALK)

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ClinicalTrials.gov Identifier: NCT02679170
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Prospective Observational Study To Identify Patients With Advanced/metastatic Non Small Cell Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management under clinical practice (IDEALK)

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Drug: Crizotinib

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: PROSPECTIVE OBSERVATIONAL STUDY TO IDENTIFY PATIENTS WITH ADVANCED/METASTATIC NSCLC AND ALK TRANSLOCATION AND TO ESTABLISH THEIR THERAPEUTIC MANAGEMENT (IDEALK)
Actual Study Start Date : June 29, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Crizotinib

Group/Cohort Intervention/treatment
Routine clinical practice group (NSCLC ALK+)
Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+
Drug: Crizotinib
Treatment with crizotinib following routine clinical practice




Primary Outcome Measures :
  1. Incidence of ALK-positive NSCLC in Spain [ Time Frame: 2 years ]
    Real incidence of ALK-positive NSCLC in Spain

  2. Progression Free Survival [PFS] [ Time Frame: 2 years ]
    Efficacy in terms of PFS of Crizotinib in patients with advanced ALK+ NSCLC



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NSCLS Patients, ALK + Confirmed
Criteria

Inclusion Criteria:

  • Patients with Advanced or metastatic non-small cell lung cancer
  • Patients who will be screened for anaplastic lymphoma kinase (ALK) rearrangement
  • Age > 18 years
  • For the patients that will be recruited prospectively: Patients must have a signed informed consent document.
  • For the treatment sub-study, patients must also meet the following criteria

    • Confirmed anaplastic lymphoma kinase (ALK)-positive tumour
    • Patients treated with crizotinib under routine clinical practice
    • Patients with a minimum data registered at the medical history

Exclusion Criteria:

  • Any patient who does not meet any of the inclusion criteria defined in the previous section, depending on the sub-study for which they are included.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679170


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Spain
Hospital Universitario de San Juan Not yet recruiting
San Juan, Alicante, Spain, 03550
Complejo Hospitalario de Jerez Recruiting
Jerez de la Frontera, Cadiz, Spain, 11407
Hospital Universitario de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Hospital Universitario Cruces Recruiting
Barakaldo, Vizcaia, Spain, 48903
Hospital Universitario de Albacete Recruiting
Albacete, Spain, 02006
Hospital Universitario Clinic i Provincial Recruiting
Barcelona, Spain, 08036
Hospital Universitario de Burgos Recruiting
Burgos, Spain, 09006
Hospital Universitario Puerta del Mar, Cádiz Recruiting
Cadiz, Spain, 11009
Complejo Hospitalario de Jaen Recruiting
Jaen, Spain, 23007
Hospital Universitario de León Recruiting
León, Spain, 24080
Hospital Universitario San Pedro, Logroño Recruiting
Logroño, Spain, 26006
Hospital Universitario Lucus Augusti (HULA_ Lugo) Recruiting
Lugo, Spain, 27003
Hospital Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Hospital Universitario Clinico San Carlos Recruiting
Madrid, Spain, 28040
Hospital Universitario Fundación Jimenez Diaz Recruiting
Madrid, Spain, 28040
H.U. La Paz Recruiting
Madrid, Spain, 28046
Hospital Universitario Arrixaca Recruiting
Murcia, Spain, 30120
Complejo Hospitalario Universitario de Ourense (CHUOU) Recruiting
Orense, Spain, 32005
HU Son Llatzer, Palma de Mallorca / Servicio de Oncología Médica Recruiting
Palma de Mallorca, Spain, 07198
Hospital Universitario de la Candelaria, Tenerife Recruiting
Santa Cruz de Tenerife, Spain, 38010
Hospital Virgen de La Salud Not yet recruiting
Toledo, Spain, 45004
Hospital Universitario de Vigo- Hospital Álvaro Cunqueiro / Servicio de Oncología Médica Recruiting
Vigo, Spain, 36312
H. Miguel Servet, Zaragoza / Servicio de Oncología Médica Not yet recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02679170     History of Changes
Other Study ID Numbers: A8081057
IDEALK ( Other Identifier: Alias Study Number )
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Keywords provided by Pfizer:
ALK+

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action