CancerNCT06402812
The Perceived Mismatch Between Dose Recommendations of PKI's and the Clinical Practice
An observational study of Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Interview
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Feb 2024to 1 Mar 2024
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Regulators and professionals
Who may be able to join
- Regulators involved in the regulation of oncolytic products. Healthcare professionals who prescribe PKI's as a treatment for cancer in clinical practice (e.g. oncologists).
Who cannot join
- No exclusion criteria will be maintained.
Trial locations and contacts
1 site in 1 country.
About this study
A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached.
Read the detailed description
- Background Protein kinase inhibitors (PKIs) are increasingly used as targeted therapy in the treatment of cancer. Currently, most PKIs are administered following the recommended dosage from the registered label based on pharmacokinetic and pharmacodynamic data, toxicity and tumor response as observed in clinical trials. Often, the recommended dose is selected based on the principle of the maximum tolerated dose (MTD). However due to pharmacokinetic and pharmacokinetic differences within patients, this registered flat starting dose often leads to toxicity. In addition, the fit and selected clinical trial patients are not always representative of the patients in clinical practice. This raises the question if the policy around dose development and recommendation is optimal. The objective of this study is therefore to increase patient safety, by exploring the perceptions of regulators and healthcare professionals on the perceived mismatch between the recommended dosage and the dose used in clinical practice for PKIs.
- Main research question What are the perceptions from regulators and healthcare professionals regarding the dosing recommendations for PKIs in clinical practice?
- Design (including population, confounders/outcomes) A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached.
- Expected results This research aims to contribute to patient safety of PKIs in cancer treatment by exploring the opinions regarding the dosing recommendations at registration and their use in clinical practice from regulators and healthcare professionals. By gathering perceptions from important, preselected, stakeholders regarding dose regulations for PKIs, substantive knowledge will be gathered on the subject. This study will increase the knowledge base on the sufficiency of the standards for dose recommendations regarding PKIs and potentially aid in the generation of new policy recommendations.
- Conditions
- Cancer
- Being tested
- Interview
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached.
| Study group | Role | What they receive |
|---|---|---|
| Regulators | Regulators Receives: Other: Interview | |
| Proefssionals | Professionals Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview
Spoken words of participants will be gathered via interviews which have been conducted following an pre-set up interview guide.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start6 Feb 2024
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther Broekman, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402812
- Sponsor's protocol ID
- 18620
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perceived Mismatch Between Dose Recommendations of PKI's and the Clinical Practice
- ClinicalTrials.gov ID
- NCT06402812
- Acronym / sponsor ID
- 18620
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 7 May 2024 (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.
A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached.
Detailed description
- Background Protein kinase inhibitors (PKIs) are increasingly used as targeted therapy in the treatment of cancer. Currently, most PKIs are administered following the recommended dosage from the registered label based on pharmacokinetic and pharmacodynamic data, toxicity and tumor response as observed in clinical trials. Often, the recommended dose is selected based on the principle of the maximum tolerated dose (MTD). However due to pharmacokinetic and pharmacokinetic differences within patients, this registered flat starting dose often leads to toxicity. In addition, the fit and selected clinical trial patients are not always representative of the patients in clinical practice. This raises the question if the policy around dose development and recommendation is optimal. The objective of this study is therefore to increase patient safety, by exploring the perceptions of regulators and healthcare professionals on the perceived mismatch between the recommended dosage and the dose used in clinical practice for PKIs.
- Main research question What are the perceptions from regulators and healthcare professionals regarding the dosing recommendations for PKIs in clinical practice?
- Design (including population, confounders/outcomes) A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached.
- Expected results This research aims to contribute to patient safety of PKIs in cancer treatment by exploring the opinions regarding the dosing recommendations at registration and their use in clinical practice from regulators and healthcare professionals. By gathering perceptions from important, preselected, stakeholders regarding dose regulations for PKIs, substantive knowledge will be gathered on the subject. This study will increase the knowledge base on the sufficiency of the standards for dose recommendations regarding PKIs and potentially aid in the generation of new policy recommendations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regulators | – | Other: InterviewRegulators |
| Proefssionals | – | Other: InterviewProfessionals |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Regulators and professionals
Key inclusion criteria (1 listed)
- Regulators involved in the regulation of oncolytic products. Healthcare professionals who prescribe PKI's as a treatment for cancer in clinical practice (e.g. oncologists).
Key exclusion criteria (1 listed)
- No exclusion criteria will be maintained.
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 |
|---|---|---|
| InterviewA qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached. | Other | Proefssionals, Regulators |
Primary outcome
Interview
Time frame: 3 months
Spoken words of participants will be gathered via interviews which have been conducted following an pre-set up interview guide.
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 7 May 2024.
- Individual participant dataSharing planned: No
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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.
Esther Broekman, MD principal investigator
University Medical Center Groningen
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 Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 1 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 7 May 2024. 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 Netherlands. 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?
Interview (time frame: 3 months). 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 7 May 2024.