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

Recruiting

• Conditions: Infectious Disorder; Chronic Disease
• Interventions: Procedure: Biospecimen Collection; Other: Medical Chart Review; Other: Questionnaire Administration

• Registration Number: NCT04160429
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study Start: 2018-11-09
• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2029-07-30
• Study Completion: 2029-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device feasibility (Macroduct Sweat Collection System)	Questionnaire Administration	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.
Device feasibility (Macroduct Sweat Collection System)	Biospecimen Collection	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.
Device feasibility (Macroduct Sweat Collection System)	Medical Chart Review	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States