Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)
NCT ID: NCT02679170
Last Updated: 2024-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
692 participants
OBSERVATIONAL
2016-06-29
2022-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Routine clinical practice group (NSCLC ALK+, ROS1)
Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+ or ROS1
Crizotinib
Treatment with crizotinib following routine clinical practice
Interventions
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Crizotinib
Treatment with crizotinib following routine clinical practice
Eligibility Criteria
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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 ALK treatment substudy (retrospective and prospective)
* Age \> 18 years
* 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
* For the patients that will be recruited prospectively: Patients must have a signed informed consent document.
For the ROS1 treatment sub-study (retrospective only):
* Age \> 18 years
* Confirmation of NSCLC with ROS1-positive translocation
* Have been eligible to receive treatment with crizotinib according to routine clinical practice since the market launch of the ROS1 indication in Spain on 8 February 2017 until the opening of the site.
* Patients should have a predetermined minimum amount of data recorded in their medical records.
19 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Hospital Clínico Univ. de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
Complejo Hospitalario de Jerez
Jerez de la Frontera, Cadiz, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital General Mancha Centro
Alcázar de San Juan, Ciudad REAL, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Cruces
Barakaldo, Vizcaia, Spain
Hospital Universitario de Albacete
Albacete, , Spain
Hospital Universitario Clinic i Provincial
Barcelona, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Hospital Universitario Puerta del Mar, Cádiz
Cadiz, , Spain
Complejo Hospitalario de Jaen
Jaén, , Spain
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, , Spain
Hospital Universitario de León
León, , Spain
Hospital Universitario San Pedro, Logroño
Logroño, , Spain
Hospital Universitario Lucus Augusti (HULA_ Lugo)
Lugo, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario Fundación Jimenez Diaz
Madrid, , Spain
H.U. La Paz
Madrid, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Hospital Universitario Arrixaca
Murcia, , Spain
Complejo Hospitalario Universitario de Ourense (CHUOU)
Ourense, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
HU Son Llatzer, Palma de Mallorca / Servicio de Oncología Médica
Palma de Mallorca, , Spain
Hospital Universitario de la Candelaria, Tenerife
Santa Cruz de Tenerife, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Virgen de La Salud
Toledo, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Hospital Universitario de Vigo- Hospital Álvaro Cunqueiro / Servicio de Oncología Médica
Vigo, , Spain
Countries
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References
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Aguado de la Rosa C, Cruz Castellanos P, Lazaro-Quintela M, Domine M, Vazquez Estevez S, Lopez-Vivanco G, Firvida Perez JL, Alonso Romero JL, Ferrera Delgado L, Garcia Giron C, Diz Tain P, Alvarez Alvarez R, Mut Sanchis P, Fernandez Canton I, Manrique Abos I, Martinez Aguillo M, Gomez-Aldaravi Gutierrez L, Ortega Granados AL, Alvarez Cabellos R, Garcia Sebastian A, Garcia Sifuentes LF, Reguart N. Identification of ALK-positive patients with advanced NSCLC and real-world clinical experience with crizotinib in Spain (IDEALK study). Lung Cancer. 2022 Nov;173:83-93. doi: 10.1016/j.lungcan.2022.09.010. Epub 2022 Sep 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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IDEALKROS
Identifier Type: OTHER
Identifier Source: secondary_id
IDEALK
Identifier Type: OTHER
Identifier Source: secondary_id
A8081057
Identifier Type: -
Identifier Source: org_study_id
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