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

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ClinicalTrials.gov Identifier: NCT04160429
Recruitment Status : Suspended (pending amendment approval)
First Posted : November 13, 2019
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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.

Condition or disease Intervention/treatment
Chronic Disease Infectious Disorder Procedure: Biospecimen Collection Other: Medical Chart Review Other: Questionnaire Administration

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Evaluate Substances in Sweat, Saliva, and Blood
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : December 9, 2021
Estimated Study Completion Date : December 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

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

Other: Medical Chart Review
Review of medical chart
Other Name: Chart Review

Other: Questionnaire Administration
Complete questionnaire




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Sweat, saliva, and blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic or infectious diseases scheduled to receive medications
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160429


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jeannine S McCune City of Hope Medical Center
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT04160429    
Other Study ID Numbers: 18380
NCI-2019-07380 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
18380 ( Other Identifier: City of Hope Comprehensive Cancer Center )
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Chronic Disease
Disease Attributes
Pathologic Processes