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Trial record 1 of 1 for:    NCT02679170
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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

Tracking Information
First Submitted Date February 5, 2016
First Posted Date February 10, 2016
Last Update Posted Date June 18, 2019
Actual Study Start Date June 29, 2016
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2016)
  • Incidence of ALK-positive NSCLC in Spain [ Time Frame: 2 years ]
    Real incidence of ALK-positive NSCLC in Spain
  • Progression Free Survival [PFS] [ Time Frame: 2 years ]
    Efficacy in terms of PFS of Crizotinib in patients with advanced ALK+ NSCLC
Original Primary Outcome Measures
 (submitted: February 5, 2016)
  • Incidence of ALK-positive NSCLC in Spain [ Time Frame: 2 years ]
    Real incidence of ALK-positive NSCLC in Spain
  • Progressioni Free Survival [PFS] [ Time Frame: 2 years ]
    Efficacy in terms of PFS of Crizotinib in patients with advanced ALK+ NSCLC
Change History Complete list of historical versions of study NCT02679170 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
Official Title PROSPECTIVE OBSERVATIONAL STUDY TO IDENTIFY PATIENTS WITH ADVANCED/METASTATIC NSCLC AND ALK TRANSLOCATION AND TO ESTABLISH THEIR THERAPEUTIC MANAGEMENT (IDEALK)
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)
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population NSCLS Patients, ALK + Confirmed
Condition Non-Small Cell Lung Cancer
Intervention Drug: Crizotinib
Treatment with crizotinib following routine clinical practice
Study Groups/Cohorts Routine clinical practice group (NSCLC ALK+)
Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+
Intervention: Drug: Crizotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 10, 2016)
100
Original Estimated Enrollment
 (submitted: February 5, 2016)
1
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02679170
Other Study ID Numbers A8081057
IDEALK ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019