Dried Blood SPOT Analysis of Everolimus in Cancer Patients (SPOT-study) (SPOT)

October 13, 2017 updated by: Radboud University Medical Center

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who are currently treated with everolimus for any type of cancer are eligible in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation everolimus concentration whole blood with saliva
Time Frame: Up to 2 years
Correlation between trough everolimus concentration from whole blood with trough everolimus concentration in saliva, measured at any time during everolimus treatment
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Nielka van Erp, PharmD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 18, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 13, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOMAM15-SPOT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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