Identification of PAthways of Kinase Inhibitors TOxicity (PAKITO)

March 28, 2019 updated by: Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
population included in VUMC database and/or WHO's database resource up to march 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborators

Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (Actual)

March 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 28, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CIC1421-1906

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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