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NCT Number: NCT04160429

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

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.

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Key information

Conditions

Chronic Disease Communicable Diseases Disease Attributes Infections Infectious Disorder Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location status: Recruiting

Location contact

Jeannine S. McCune

CONTACT

[email protected]

626-218-4611

Jeannine S. McCune

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of sweat, saliva, and blood samples

medical chart review

Other

Review of medical chart

Other names: Chart Review

Questionnaire Administration

Other

Complete questionnaire

Primary outcomes

  1. Predictive performance of the home-based sampling

    Time frame: 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).

  2. Observed plasma concentrations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2029
Study completion
2029
First posted
Nov 13, 2019
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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