NCT04160429

Biospecimen Analysis in Detecting Chemical Concentrations in Patients With Chronic or Infectious Diseases Receiving Meditations

Pilot Study to Evaluate Substances in Sweat, Saliva, and Blood

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Disease
• Infectious Disorder

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of sweat, saliva, and blood samples
OTHER	Medical Chart Review	Review of medical chart
OTHER	Questionnaire Administration	Complete questionnaire

Timeline

• Start date: 2018-11-09
• Primary completion: 2029-07-30
• Completion: 2029-07-30
• First posted: 2019-11-13
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States