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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

Study Description
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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.

Condition or disease Intervention/treatment
Kinase Inhibitors Toxicity Drug: Kinase inhibitor

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 20 Years
Official Title: Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
VUMC EHR cohort
De-identified version of the electronic health record (EHR) at Vanderbilt University Medical Center (VUMC).
 Drug: Kinase inhibitor
Patients treated with kinase inhibitors for cancer or other conditions
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
 Drug: Kinase inhibitor
Patients treated with kinase inhibitors for cancer or other conditions


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896139


Locations
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France
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris, France
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Vanderbilt University Medical Center
More Information
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Additional Information:

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Responsible Party: Joe Elie Salem, Investigator, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03896139     History of Changes
Other Study ID Numbers: CIC1421-1906
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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