Remote Temperature Data for Early Detection of Febrile Neutropenia

NCT05180838 | Completed DMC

• 1 other identifier: 20-2517.cc
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Hematologic Malignancy

Keywords

Cytotoxic Chemotherapy; Stem cell transplant; CAR T-cell treatments

Outcome Measures

Primary Outcomes (1)

• Reliability of BioSticker compared to self-check

  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.

  28 days

Secondary Outcomes (4)

• BioSticker Impact on Patient reported temperature

  28 days

• BioSticker Impact on Length of Hospitalization

  28 days

• BioSticker Impact on ICU transfers

  28 days

• BioSticker Impact on Delays in Chemotherapy

  28 days

Study Arms (1)

BioSticker

This cohort will place BioStickers at least 3 days prior to completion of standard of care therapy and discharge home post therapy.

Device: BioSticker

Interventions

BioSticker DEVICE

The BioSticker is an FDA approved medical device which can be worn on the upper left chest for remote data capture and can provide for up 30 days of continuous vital sign monitoring

BioSticker

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

20 patients with leukemia, lymphoma, myeloma and other blood cancers undergoing treatment with cytotoxic chemotherapy, stem cell transplant or CAR T-cells following IRB consent. Patients will be included who are \>18 years old, 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, are capable of informed consent and agree to collect a self-check temperature log.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• BioIntelliSense, Inc: collaborator

Study Sites (2)

Colorado Research Center

Aurora, Colorado, 80045, United States

Location

UCHealth-Metro Denver

Denver, Colorado, 80217-3364, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Glen Peterson

  Colorado Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: January 6, 2022
• Study Start: October 7, 2021
• Primary Completion: September 1, 2022
• Study Completion: March 31, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)