Chronic Disease, Infectious Disorder
Conditions
Brief summary
This trial collects and analyzes sweat and saliva samples compared to blood in detecting chemical concentrations in the body in patients with chronic or infectious diseases receiving medications. Wearable sweat sensors are capable of monitoring electrolytes and metabolites (sodium, potassium, glucose, lactate, etc.) for health monitoring and disease diagnosis. Designing wearable sweat sensors capable of providing information regarding drug administration may be challenging due to ultralow concentrations in biofluids. This trial seeks to determine if the use of a smart wristband can accurately measure the levels of chemicals and substances in sweat.
Detailed description
PRIMARY OBJECTIVE: I. To compare novel, home-based methods of quantitating medication concentrations in either saliva or sweat to the 'gold standard' of liquid chromatography - mass spectrometry of plasma. SECONDARY OBJECTIVES: I. To compare novel home-based methods of quantitating substances in either saliva or sweat to the 'gold standard' in plasma. II. Assess the ease of obtaining home-based samples. OUTLINE: Patients undergo collection of sweat samples via Macroduct Sweat Collection System 3710S and saliva and blood samples within 24 hours after medication administrations. Patients also complete questionnaires over 5-10 minutes and have medical charts reviewed. After completion of study, patients are followed up periodically.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of sweat, saliva, and blood samples
OTHERMedical Chart Review
Review of medical chart
OTHERQuestionnaire Administration
Complete questionnaire
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled to receive medications including, but not limited to, cyclophosphamide, mycophenolic acid, mycophenolate mofetil, metformin or busulfan (any dose, any number of doses, any dosing frequency) as part of treatment at any time. Patients with chronic or infectious diseases can participate * Willingness to: * Provide blood, sweat, and saliva samples * Permit medical record review
Exclusion criteria
* Pilocarpine allergy * Difficulty with understanding written English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive performance of the home-based sampling | Up to 4 hours | Will be assessed by Pearson correlation and quantification of the predictive performance. The predictive performance of the home-based sampling methods will be assessed by calculating the median percentage prediction error (MPPE). |
| Observed plasma concentrations | Up to 4 hours | Will be assessed by Pearson correlation and quantification of the predictive performance. The values from plasma will be considered the observed concentration. |
Countries
United States
Outcome results
None listed