Clinical trial NCT02809404: Dried Blood SPOT Analysis of Everolimus in Cancer Patients (SPOT-study)
Official title: Dried Blood SPOT Analysis of Everolimus in Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Renal Cell Carcinoma
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are currently treated with everolimus for any type of cancer are eligible in this study.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* None

Primary outcomes:
measure: Correlation everolimus concentration DBS with whole blood
timeFrame: Up to 2 years
Secondary outcomes:
measure: Correlation everolimus concentration whole blood with saliva
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
affiliation: Radboud University Medical Center
name: Nielka van Erp, PharmD
role: PRINCIPAL_INVESTIGATOR
References: