Hematopoietic and Lymphatic System NeoplasmNCT07612085

A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery

A study testing Biospecimen Collection, Electronic Health Record Review and Interview in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
What is being tested?: Biospecimen Collection, Electronic Health Record Review and Interview
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2026to 15 Apr 2027
Phase: Interventional

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

Who may be able to join

Age ≥ 18 years
Scheduled to have an elective abdominal or thoracic operation with anticipated post-operative hospitalization ≥ 3 days
Willingness to provide sweat samples, complete surveys, and permit review of medical records for research use
Ability to consent to the study procedures

Who cannot join

Carbachol or pilocarpine allergy
Adhesive/tape allergy
Damaged or irritated skin on one or both wrists that prohibits placement of the biosensor and sweat collecting devices
Pregnant women
Children less than 18 years of age

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

City of Hope Medical Center
Duarte, California, 91010
Kelly Mahuron, 626-256-4673 ext. 89200, kmahuron@coh.org
Kelly Mahuron

Other trials in United States

About this study

Official title: Pilot Study on the Clinical Application of a Wearable Biosensor Patch for Non-Invasive Measurement of Biochemical and Blood Gas Analytes

This clinical trial tests the feasibility and safety of a wearable biosensor patch for non-invasive monitoring for patients undergoing abdominal or chest surgery. Wearable biosensor patches have been developed by researchers to provide a non-invasive way to monitor substances that are normally checked using blood tests. This may reduce the need for frequent blood draws. The patches use gentle electrical stimulation to produce sweat and tiny built-in sensors to measure substances such as glucose, creatinine, and markers of inflammation, as well as oxygen and carbon dioxide levels. The wearable biosensor patch may be a feasible and safe way to monitor patients undergoing abdominal or chest surgery.

Read the detailed description

PRIMARY OBJECTIVE:

To evaluate the feasibility of data collection using wearable postoperative biosensor patch.

SECONDARY OBJECTIVES:

To evaluate patient acceptability with using the wearable biosensor patch. II. To evaluate the safety of the wearable biosensor patch. III. To assess processes and resources needed to deploy the wearable biosensor patches postoperatively.

EXPLORATORY OBJECTIVES:

To explore the consistency of sweat analyte concentrations obtained using the wearable biosensor patch and a standard sweat collector.

II. To explore the accuracy of sweat-derived analyte concentrations relative to peripheral blood measurements (gold standard).

III. To explore the feasibility of intraoperative blood gas monitoring using a transcutaneous biosensor patch measuring oxygen (O₂) and carbon dioxide (CO₂).

IV. To explore the accuracy of O₂ and CO₂ concentrations obtained from the transcutaneous biosensor patch relative to paired intraoperative blood gas measurements (gold standard).

OUTLINE:

Patients have the wearable biosensor patch placed on the upper back or shoulder during surgery and wear it for the duration of the surgery to monitor oxygen and carbon dioxide levels. Starting the day after surgery, patients wear a biosensor patch on their wrist along with a sweat collecting chamber for 2-4 hours, up to twice daily, for up to 3 days post-operatively.

After completion of study intervention, patients may be followed up for up to 1 year.

Conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Being tested: Biospecimen Collection, Electronic Health Record Review, Interview, Survey Administration, Wearable Biosensor Patch

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo sweat sample collection
Electronic Health Record ReviewOther
Ancillary studies
InterviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
Wearable Biosensor PatchDevice
Wear biosensor patch

Study groups in NCT07612085
Study group	Role	What they receive
Diagnostic (wearable biosensor patch)	Experimental	Patients have the wearable biosensor patch placed on the upper back or shoulder during surgery and wear it for the duration of the surgery to monitor oxygen and carbon monoxide levels. Starting the day after surgery, patients wear a biosensor patch on their wrist along with a sweat collecting chamber for 2-4 hours, up to twice daily, for up to 3 days post-operatively. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Interview; Other: Survey Administration; Device: Wearable Biosensor Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of successful sweat collections (feasibility)
A successful collection will be defined by patch application with data successfully recorded and sent to the database. Examples of failed collections include, but are not limited to, a patch falling off before data collection can occur or a patch failing to collect and send data to the database. The number of successful collections will be reported as a proportion of the total number of attempted applications. All analyses will be descriptive. Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages. Given the small sample, two-sided 95 percent exact (Clopper-Pearson) confidence intervals will be provided for proportions. In addition to the overall success rate, the success rates for each type of patch (intraoperative and postoperative) will be described. All causes of failure (including unknown causes) will be reported.
Measured: Up to 1 year

Secondary outcomes (3)

Acceptability of the intervention
Assessed using Acceptability of Intervention Measure (AIM) scores and qualitative data analysis of patient exit interviews. Scores will be summarized descriptively. Exit interviews will be conducted to explore subjective experience with the biosensor patch. Topics will include comfort/discomfort while wearing the patch, comfort/discomfort during application and removal, and open-ended feedback. All analyses will be descriptive. Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
Measured: Up to 1 year
Incidence of treatment related adverse events related to biosensor use
Safety will be evaluated based on the incidence of treatment-emergent adverse events deemed definitely, probably, or possibly related to the biosensor device. Adverse events will be graded using the Common Terminology Criteria for Adverse Events version 5.0. All analyses will be descriptive. Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
Measured: Up to 1 year
Processes and resources needed to deploy the wearable biosensor patches postoperatively
Processes and resources needed to deploy the biosensor patches will be assessed through one focus group. Topics will include: approximate time to setting up the patch for patients and applying them, barriers and facilitators in deploying the patches, and open-ended feedback. All analyses will be descriptive. Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202615 Apr 2027

First posted28 May 2026
Study start1 Dec 2026 (estimated)
Primary completion15 Apr 2027 (estimated)
Study completion15 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hematopoietic and Lymphatic System NeoplasmStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07612085
Sponsor's protocol ID: 25132
Other IDs: NCI-2026-03601, 25132, P30CA033572
Status last verified: Oct 2026
First submitted: 21 May 2026
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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