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Identification of PAthways of Kinase Inhibitors TOxicity (PAKITO)

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ClinicalTrials.gov Identifier: NCT03896139
Recruitment Status : Completed
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

Tracking Information
First Submitted Date March 25, 2019
First Posted Date March 29, 2019
Last Update Posted Date March 29, 2019
Actual Study Start Date January 1, 2017
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2019)
Comparison of the incidence of kinase inhibitor (KIs) induced toxicities in health records and their associations with co-medications to identify new mechanisms of drug induced toxicity [ Time Frame: population included in VUMC database and/or WHO's database resource up to march 2019 ]
Identification of a mechanism of a toxicity associated with a KI using comedications and comparing it to reported outcomes
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 Identification of PAthways of Kinase Inhibitors TOxicity
Official Title Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases
Brief Summary The investigators are identifying clinical diagnoses and toxicities associated with kinase inhibitors prescription. This identification will be applied will be applied in an electronic-health-record (EHR) cohort including North American and European.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 20 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated with kinase inhibitors or drugs targeting kinase pathways for a cancer with at least one report accessible in the VUMC electronic health record database and/or in VigiBase, the WHO's international pharmacovigilance database.
Condition Kinase Inhibitors Toxicity
Intervention Drug: Kinase inhibitor
Patients treated with kinase inhibitors for cancer or other conditions
Study Groups/Cohorts
  • VUMC EHR cohort
    De-identified version of the electronic health record (EHR) at Vanderbilt University Medical Center (VUMC).
    Intervention: Drug: Kinase inhibitor
  • Toxicity induced by kinase inhibitors in Vigibase database
    Case reported in the World Health Organization (WHO) of toxicity or complication of patient treated by KIs, with a chronology compatible with the drug toxicity
    Intervention: Drug: Kinase inhibitor
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
 (submitted: March 28, 2019)
4000
Original Actual Enrollment Same as current
Actual Study Completion Date March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient treated with a kinase inhibitor
  • Patient identified in the VUMC EHR cohort or having a toxicity reported in the VigiBase

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages Child, 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 NCT03896139
Other Study ID Numbers CIC1421-1906
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
Study Sponsor Groupe Hospitalier Pitie-Salpetriere
Collaborators Vanderbilt University Medical Center
Investigators Not Provided
PRS Account Groupe Hospitalier Pitie-Salpetriere
Verification Date March 2019