Trial record 1 of 1 for:
NCT03718117
Descriptive Observational Study ALK-2016-CPHG (ALK2016CPHG)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03718117 |
Recruitment Status :
Completed
First Posted : October 24, 2018
Last Update Posted : September 18, 2020
|
Sponsor:
Pfizer
Collaborator:
French College of General Hospital Pneumologists (CPHG)
Information provided by (Responsible Party):
Pfizer
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | March 5, 2018 | ||||
First Posted Date | October 24, 2018 | ||||
Last Update Posted Date | September 18, 2020 | ||||
Actual Study Start Date | January 3, 2017 | ||||
Actual Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Demographical Characteristics of Participants [ Time Frame: Baseline up tp Month 18 ] | ||||
Original Primary Outcome Measures |
|
||||
Change History | |||||
Current Secondary Outcome Measures |
|
||||
Original Secondary Outcome Measures |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Descriptive Observational Study ALK-2016-CPHG | ||||
Official Title | CHARACTERISTICS OF ADULT PATIENTS TREATED WITH CRIZOTINIB FOR ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) WITH ALK GENE REARRANGEMENT OR ROS1 GENE REARRANGEMENT IN GENERAL HOSPITALS. | ||||
Brief Summary | Descriptive Observational Study. Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals |
||||
Detailed Description | Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL. | ||||
Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
Target Follow-Up Duration | 18 Months | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Participants with ALK positive or ROS1-positive Locally advanced or metastatic non-small cell lung cancer NSCLC, initiated in the previous 3 months or participants initiating crizotinib treatment regardless of the line of treatment | ||||
Condition |
|
||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
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 | Completed | ||||
Actual Enrollment |
71 | ||||
Original Estimated Enrollment |
70 | ||||
Actual Study Completion Date | July 1, 2020 | ||||
Actual Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion criteria
Non-inclusion criteria
|
||||
Sex/Gender |
|
||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03718117 | ||||
Other Study ID Numbers | A8081060 ALK-2016-CPHG ( Other Identifier: Alias Study Number ) |
||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement |
|
||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | French College of General Hospital Pneumologists (CPHG) | ||||
Investigators |
|
||||
PRS Account | Pfizer | ||||
Verification Date | September 2020 |