Chronic DiseaseNCT04160429
Biospecimen Analysis in Detecting Chemical Concentrations in Patients With Chronic or Infectious Diseases Receiving Meditations
An observational study of Chronic Disease and Infectious Disorder, run by City of Hope Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Infectious Disorder
- What is being tested?
- Biospecimen Collection, Medical Chart Review and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2018to 30 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic or infectious diseases scheduled to receive medications
Who may be able to join
- 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
Who cannot join
- Pilocarpine allergy
- Difficulty with understanding written English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Jeannine S. McCune, 626-218-4611, JMCCUNE@coh.org
Jeannine S. McCune
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Chronic Disease, Infectious Disorder
- Being tested
- Biospecimen Collection, Medical Chart Review, Questionnaire Administration
- Medical subject headings
- Chronic Disease, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of sweat, saliva, and blood samples
Medical Chart ReviewOther
Also called Chart Review
Review of medical chart
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Medical Chart Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start30 Oct 2018
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeannine S McCune, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160429
- Sponsor's protocol ID
- 18380
- Other IDs
- NCI-2019-07380, 18380
- Status last verified
- Oct 2026
- First submitted
- 8 Nov 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Substances in Sweat, Saliva, and Blood
- ClinicalTrials.gov ID
- NCT04160429
- Acronym / sponsor ID
- 18380
- Conditions
- Chronic Disease, Infectious Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device feasibility (Macroduct Sweat Collection System) | – | Procedure: Biospecimen Collection, Other: Medical Chart Review, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic or infectious diseases scheduled to receive medications
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (2 listed)
- Pilocarpine allergy
- Difficulty with understanding written English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of sweat, saliva, and blood samples | Procedure or surgery | Device feasibility (Macroduct Sweat Collection System) |
| Medical Chart ReviewAlso: Chart ReviewReview of medical chart | Other | Device feasibility (Macroduct Sweat Collection System) |
| Questionnaire AdministrationComplete questionnaire | Other | Device feasibility (Macroduct Sweat Collection System) |
Primary outcome
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeannine S McCune principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and Infectious Disorder, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of the home-based sampling (time frame: Up to 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.