Clinical trial · Observational
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)
Observational Study to IDEntify Patients With Advanced/Metastatic NSCLC and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)
NCT02679170CI-TRIAL-00079639completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective observational study to IDEntify patients with advanced/metastatic NSCLC and ALK and ROS1 translocation and to establish their therapeutic management (IDEALK\&ROS)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crizotinib | Drug | Crizotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Routine clinical practice group (NSCLC ALK+, ROS1)
- description
- Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+ or ROS1
- interventionNames
- Drug: Crizotinib
Primary outcomes (18)
- measure
- Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only
- timeFrame
- At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)
- description
- ECOG quality of life score is a rating of a participant's disease status, daily living activities and quality of life, where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG quality of life scores were reported in this outcome measure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: For ALK Incidence substudy * 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. 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.
References
Publications (1)
- DERIVEDAguado 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. PMID 36162227