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

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04160429
• Other study ID #: 18380
• Secondary ID: NCI-2019-0738018
• Status: Recruiting
• Start date: November 9, 2018
• Est. completion date: October 5, 2024

Study information

• Verified date: January 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 5, 2024
• Est. primary completion date: October 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Communicable Diseases
• Infections
• Infectious Disorder

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of sweat, saliva, and blood samples

Other:
• Medical Chart Review
Review of medical chart
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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