Biospecimen Analysis in Detecting Chemical Concentrations in Patients With Chronic or Infectious Diseases Receiving Meditations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Medical Chart Review, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Chronic Disease, Infectious Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study to Evaluate Substances in Sweat, Saliva, and Blood
Overview
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.
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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of sweat, saliva, and blood samples - Other Medical Chart Review
Review of medical chart - Other Questionnaire Administration
Complete questionnaire
Primary outcome measures
- Predictive performance of the home-based sampling [Time frame: Up to 4 hours]
- Observed plasma concentrations [Time frame: Up to 4 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT04160429 · 18380 · NCI-2019-07380 · 18380