Kinase Inhibitors ToxicityPAKITONCT03896139
Identification of PAthways of Kinase Inhibitors TOxicity
An observational study of Kinase Inhibitors Toxicity, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kinase Inhibitors Toxicity
- What is being tested?
- Kinase inhibitor
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 1 Mar 2019
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patient treated with a kinase inhibitor
- Patient identified in the VUMC EHR cohort or having a toxicity reported in the VigiBase
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris
About this study
Official title: 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.
- Conditions
- Kinase Inhibitors Toxicity
- Being tested
- Kinase inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinase inhibitorDrug
Patients treated with kinase inhibitors for cancer or other conditions
| Study group | Role | What they receive |
|---|---|---|
| VUMC EHR cohort | De-identified version of the electronic health record (EHR) at Vanderbilt University Medical Center (VUMC). Receives: 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 Receives: Drug: Kinase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: population included in VUMC database and/or WHO's database resource up to march 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Jan 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kinase Inhibitors ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896139
- Sponsor's protocol ID
- CIC1421-1906
- Acronym
- PAKITO
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases
- ClinicalTrials.gov ID
- NCT03896139
- Acronym / sponsor ID
- PAKITO / CIC1421-1906
- Conditions
- Kinase Inhibitors Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VUMC EHR cohort | – | Drug: Kinase inhibitorDe-identified version of the electronic health record (EHR) at Vanderbilt University Medical Center (VUMC). |
| Toxicity induced by kinase inhibitors in Vigibase database | – | Drug: Kinase inhibitorCase reported in the World Health Organization (WHO) of toxicity or complication of patient treated by KIs, with a chronology compatible with the drug toxicity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patient treated with a kinase inhibitor
- Patient identified in the VUMC EHR cohort or having a toxicity reported in the VigiBase
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinase inhibitorPatients treated with kinase inhibitors for cancer or other conditions | Drug | Toxicity induced by kinase inhibitors in Vigibase database, VUMC EHR cohort |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kinase Inhibitors Toxicity, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.