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Identification of PAthways of Kinase Inhibitors TOxicity

NCT ID: NCT03896139

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-03-01

Brief Summary

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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

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Conditions

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Kinase Inhibitors Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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VUMC EHR cohort

De-identified version of the electronic health record (EHR) at Vanderbilt University Medical Center (VUMC).

Kinase inhibitor

Intervention Type DRUG

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

Kinase inhibitor

Intervention Type DRUG

Patients treated with kinase inhibitors for cancer or other conditions

Interventions

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Kinase inhibitor

Patients treated with kinase inhibitors for cancer or other conditions

Intervention Type DRUG

Eligibility Criteria

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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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Joe Elie Salem

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CIC1421-1906

Identifier Type: -

Identifier Source: org_study_id