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RecruitingNCT04160429Updated Nov 10, 2025

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

An observational study in Chronic Disease and Infectious Disorder, sponsored by City of Hope Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-10.

Sponsored by City of Hope Medical Center · Observational

From the registry’s dates

  • Started Nov 2018; still recruiting 7 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Disease
  • Infectious Disorder
03

In context

Chronic Disease

990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.

This study's planned enrollment of 100 is below the median of 419 across 249 observational studies indexed under Chronic Disease.

Browse Chronic Disease studies →

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with chronic or infectious diseases scheduled to receive medications

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

Exclusion Criteria:

  • Pilocarpine allergy
  • Difficulty with understanding written English
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Procedure: Biospecimen Collection · Other: Medical Chart Review · Other: Questionnaire Administration

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of sweat, saliva, and blood samples

  • OtherMedical Chart Review

    Review of medical chart

    Also known as: Chart Review

  • OtherQuestionnaire Administration

    Complete questionnaire

06

What researchers measure

Primary outcomes

  1. Predictive performance of the home-based sampling

    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).

    Time frame: Up to 4 hours

  2. Observed plasma concentrations

    Will be assessed by Pearson correlation and quantification of the predictive performance. The values from plasma will be considered the observed concentration.

    Time frame: Up to 4 hours

07

Study locations

1 of 1 sites recruiting
  • City of Hope Medical Center
    Duarte, California 91010, United States
    • Jeannine S. McCune · Contact · JMCCUNE@coh.org · 626-218-4611
    • Jeannine S. McCune · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04160429
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 13, 2019
Start date
Nov 9, 2018
Primary completion
Jul 30, 2029 (estimated)
Completion
Jul 30, 2029 (estimated)
Last update
Nov 10, 2025

Study contacts

Jeannine S McCune
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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