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

NCT04160429 | Recruiting

• 2 other identifiers: 18380NCI-2019-07380
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Biospecimen Collection PROCEDURE

Undergo collection of sweat, saliva, and blood samples

Device feasibility (Macroduct Sweat Collection System)

Medical Chart Review OTHER

Review of medical chart

Also known as: Chart Review

Device feasibility (Macroduct Sweat Collection System)

Questionnaire Administration OTHER

Complete questionnaire

Device feasibility (Macroduct Sweat Collection System)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic or infectious diseases scheduled to receive medications

You may qualify if:

• 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

You may not qualify if:

• Pilocarpine allergy
• Difficulty with understanding written English

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sweat, saliva, and blood

MeSH Terms

Conditions

Chronic Disease; Communicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Jeannine S McCune

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: November 9, 2018
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2029
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)