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)
NCT02679170
ABOUT THIS STUDY
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- 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
- 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.
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Descriptive Information | |||||
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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 | 100 | ||||
Original Estimated Enrollment | 1 | ||||
Estimated Study Completion Date | December 31, 2021 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 19 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | September 2020 |