Clinical trial · Observational
Remote Temperature Data for Early Detection of Febrile Neutropenia
Remote Data Capture of Elevated Temperature Data for Early Detection of Febrile Neutropenia in Patients With Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of \~1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BioSticker | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- BioSticker
- description
- This cohort will place BioStickers at least 3 days prior to completion of standard of care therapy and discharge home post therapy.
- interventionNames
- Device: BioSticker
Primary outcomes (1)
- measure
- Reliability of BioSticker compared to self-check
- timeFrame
- 28 days
- description
- Patients will self-temperature check every 6 hours or at least two times per day, and will log these temperatures in a paper record with date, time and temperature noted.
Secondary outcomes (4)
- measure
- BioSticker Impact on Patient reported temperature
- timeFrame
- 28 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Ages 18-80 years (inclusive) * Provision to sign and date the consent form. * Diagnosed with a hematologic malignancy and undergoing cytotoxic chemotherapy, stem cell transplants or CAR T-cell treatments at the Blood Disorders and Cell Therapies Center at UCHealth (BDCTC) * Will have longitudinal care provided by the BDCTC for \>1 additional month * Receive chemotherapy or other therapies known to cause reductions in WBC \<1000 on a routine basis * Scheduled to be discharged home and self-monitor for FN and other complications * Patient is willing to tell TSA or any security representative that you are wearing a "medical device" * Patient has agreed to not submerge the device underwater including while swimming or bathing * Patient is willing to complete a self-check temperature log comply and be available for the duration of the study * Patient has access to a thermometer Exclusion Criteria: * Patient that wears a defibrillator, pacemaker, or other implantable device * Patient has broken skin including wounds, sores, or abrasions in the area that the BioSticker would be applied * Patient has had a severe reaction to silicone adhesives * Patient has any clinically significant medical or psychiatric disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
References
Publications (0)
Data not yet available