Breast CancerSPOTNCT02809404
Dried Blood SPOT Analysis of Everolimus in Cancer Patients (SPOT-study)
An observational study of Breast Cancer and Renal Cell Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Everolimus shows a large interpatient variability with fixed dose administration. These very different exposure levels between individuals can result in supratherapeutic or subtherapeutic exposure levels and consequently in over- or undertreatment, respectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Renal Cell Carcinoma
- What is being tested?
- Everolimus
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are currently treated with everolimus for any type of cancer are eligible in this study.
Who may be able to join
- Patients currently treated with everolimus for any type of cancer
- Patients from whom it is possible to collect blood samples
- At least 18 years of age
- Able and willing to sign the Informed Consent Form prior to study assessments.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dried Blood SPOT Analysis of Everolimus in Cancer Patients
Everolimus shows a large interpatient variability with fixed dose administration. These very different exposure levels between individuals can result in supratherapeutic or subtherapeutic exposure levels and consequently in over- or undertreatment, respectively. Dose individualization based on the measured drug concentration could theoretically result in less toxicity and more efficacy.
Nowadays everolimus exposure is determined by everolimus concentration in whole blood. Therefore, a vena puncture is always necessary. This is invasive and requires patients to come to the hospital. It would be convenient for patients to have their everolimus blood concentration determined by dried blood spot (DBS) analysis. With DBS only a single drop of blood from the finger is necessary, which can be done at home and sent by regular mail for analysis. Previous studies have shown the feasibility of this approach. In patients with cancer treated with everolimus 10mg once daily, the correlation between everolimus DBS concentrations and whole blood concentration is yet unknown. Therefore, the investigators want to determine the everolimus concentration collected with DBS from a finger prick with everolimus concentration from whole blood and everolimus concentration collected with DBS from whole blood.
Read more
In addition, possibly a relatively high everolimus concentration in saliva could be correlated with the incidence and severity of oral mucositis. Determination of drug concentration in saliva has also been proven to be feasible before.
Therefore, in this study the investigators want to determine whether the everolimus concentration in saliva correlates with the incidence of oral mucositis and how everolimus concentration in saliva correlates with everolimus concentration in whole blood.
- Conditions
- Breast Cancer, Renal Cell Carcinoma
- Being tested
- Everolimus
- Medical subject headings
- Breast Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Afinitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation everolimus concentration DBS with whole blood
Correlation between trough everolimus concentration from DBS analysis collected with finger prick with trough everolimus concentration in whole blood, measured at any time during everolimus treatment
Measured: Up to 2 years
Secondary outcomes (1)
Correlation everolimus concentration whole blood with saliva
Correlation between trough everolimus concentration from whole blood with trough everolimus concentration in saliva, measured at any time during everolimus treatment
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nielka van Erp, PharmD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809404
- Sponsor's protocol ID
- MOMAM15-SPOT
- Acronym
- SPOT
- Status last verified
- May 2016
- First submitted
- 1 Jun 2016
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dried Blood SPOT Analysis of Everolimus in Cancer Patients
- ClinicalTrials.gov ID
- NCT02809404
- Acronym / sponsor ID
- SPOT / MOMAM15-SPOT
- Conditions
- Breast Cancer, Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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.
Everolimus shows a large interpatient variability with fixed dose administration. These very different exposure levels between individuals can result in supratherapeutic or subtherapeutic exposure levels and consequently in over- or undertreatment, respectively. Dose individualization based on the measured drug concentration could theoretically result in less toxicity and more efficacy.
Nowadays everolimus exposure is determined by everolimus concentration in whole blood. Therefore, a vena puncture is always necessary. This is invasive and requires patients to come to the hospital. It would be convenient for patients to have their everolimus blood concentration determined by dried blood spot (DBS) analysis. With DBS only a single drop of blood from the finger is necessary, which can be done at home and sent by regular mail for analysis. Previous studies have shown the feasibility of this approach. In patients with cancer treated with everolimus 10mg once daily, the correlation between everolimus DBS concentrations and whole blood concentration is yet unknown. Therefore, the investigators want to determine the everolimus concentration collected with DBS from a finger prick with everolimus concentration from whole blood and everolimus concentration collected with DBS from whole blood.
In addition, possibly a relatively high everolimus concentration in saliva could be correlated with the incidence and severity of oral mucositis. Determination of drug concentration in saliva has also been proven to be feasible before.
Therefore, in this study the investigators want to determine whether the everolimus concentration in saliva correlates with the incidence of oral mucositis and how everolimus concentration in saliva correlates with everolimus concentration in whole blood.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are currently treated with everolimus for any type of cancer are eligible in this study.
Key inclusion criteria (4 listed)
- Patients currently treated with everolimus for any type of cancer
- Patients from whom it is possible to collect blood samples
- At least 18 years of age
- Able and willing to sign the Informed Consent Form prior to study assessments.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| EverolimusAlso: Afinitor | Drug | – |
Primary outcome
Correlation everolimus concentration DBS with whole blood
Time frame: Up to 2 years
Correlation between trough everolimus concentration from DBS analysis collected with finger prick with trough everolimus concentration in whole blood, measured at any time during everolimus treatment
1 secondary outcome
Correlation everolimus concentration whole blood with saliva
Time frame: Up to 2 years
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 16 Oct 2017.
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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.
Nielka van Erp, PharmD principal investigator
Radboud University Medical Center
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 Breast Cancer and Renal Cell Carcinoma, run by Radboud University Medical Center 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 4 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 16 Oct 2017. 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?
Correlation everolimus concentration DBS with whole blood (time frame: Up to 2 years). 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 16 Oct 2017.