Identification of PAthways of Kinase Inhibitors TOxicity

NCT03896139 | Completed DMC FDA Drug

• 1 other identifier: CIC1421-1906
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Kinase Inhibitors Toxicity

Outcome Measures

Primary Outcomes (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

  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

Study Arms (2)

VUMC EHR cohort

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

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

Drug: Kinase inhibitor

Interventions

Kinase inhibitor DRUG

Patients treated with kinase inhibitors for cancer or other conditions

Toxicity induced by kinase inhibitors in Vigibase database; VUMC EHR cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

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

Paris, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 29, 2019
• Study Start: January 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

FR (1)