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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease; Infectious Disorder
• Intervention / Treatment: Other: Medical Chart Review; Other: Questionnaire Administration; Procedure: Biospecimen Collection

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Jeannine S. McCune; Phone Number: 626-218-4611; Email: JMCCUNE@coh.org
      • Principal Investigator: Jeannine S. McCune

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic or infectious diseases scheduled to receive medications

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Medical Chart Review; Review of medical chart; Other Names: Chart Review; Other: Questionnaire Administration; Complete questionnaire; Procedure: Biospecimen Collection; Undergo collection of sweat, saliva, and blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 4 hours
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.	Up to 4 hours

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jeannine S McCune, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Estimated): October 5, 2024
• Study Completion (Estimated): October 5, 2024

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Chronic Disease
• Other Study ID Numbers: 18380 (Other Identifier: City of Hope Comprehensive Cancer Center); NCI-2019-07380 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No