Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02809404
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.
Study:
NCT02809404
Study Brief:
Protocol Section:
NCT02809404