Recruiting

Biospecimen Analysis

Sponsor:

City of Hope Medical Center

Code:

NCT04160429

Conditions

Chronic Disease

Infectious Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Medical Chart Review

Questionnaire Administration

Study Details

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.

Conditions

Chronic Disease

Infectious Disorder

Study ID

NCT04160429

Start date

Nov 9, 2018

Status verified date

Nov, 2025

Completion date

Jul 30, 2029

Anticipated

Primary completion date

Jul 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Device feasibility (Macroduct Sweat Collection System)

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.

Interventions

Biospecimen Collection

Undergo collection of sweat, saliva, and blood samples

Medical Chart Review

Review of medical chart

Questionnaire Administration

Complete questionnaire

Primary outcome measure

  • Predictive performance of the home-based sampling [ Time Frame: Up to 4 hours ]
  • Observed plasma concentrations [ Time Frame: Up to 4 hours ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Jeannine S. McCune

626-218-4611JMCCUNE@coh.org

Principal Investigator:

Jeannine S. McCune

More Information

Sponsor

City of Hope Medical Center

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-11-10.