Hematologic MalignancyNCT05180838
Remote Temperature Data for Early Detection of Febrile Neutropenia
An observational study of Hematologic Malignancy, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- BioSticker
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2021to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Colorado Research Center
Aurora, Colorado, 80045
UCHealth-Metro Denver
Denver, Colorado, 80217-3364
About this study
Official title: Remote Data Capture of Elevated Temperature Data for Early Detection of Febrile Neutropenia in Patients With Hematologic Malignancies
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.
Read the detailed description
The BioIntelliSense BioSticker potentially offers a solution to these challenges through early and reliable detection of elevated temperature and perhaps other relevant physiologic changes. 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 (see https://biointellisense.com as well as attached documents on BioSticker instructions for a full description and use instructions). The BioSticker detects the following:
- Respiratory rate, heart rate at rest and skin temperature
- Body position, activity levels, sleep status
- High-resolution gait analysis and fall detection
- Symptomatic events
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
- Being tested
- BioSticker
- Keywords
- Cytotoxic Chemotherapy, Stem cell transplant, CAR T-cell treatments
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioStickerDevice
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
| Study group | Role | What they receive |
|---|---|---|
| BioSticker | This cohort will place BioStickers at least 3 days prior to completion of standard of care therapy and discharge home post therapy. Receives: Device: BioSticker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (4)
BioSticker Impact on Patient reported temperature
Patients will report a single oral temperature of ≥38.3°C (101°F) or a temperature of ≥38.0°C (100.4°F) sustained over a one-hour period to our clinic nurses or 24/7 on-call advanced practitioner and will be directed to the Emergency Department or clinic for initiation of antibiotics and FN work-up and management as per usual practice.
Measured: 28 days
BioSticker Impact on Length of Hospitalization
Hospitalization during the 28 days will be extracted from the medical record
Measured: 28 days
BioSticker Impact on ICU transfers
ICU transfers during the 28 days will be extracted from the medical record
Measured: 28 days
BioSticker Impact on Delays in Chemotherapy
Delays in chemotherapy during the 28 days will be extracted from the medical record
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start7 Oct 2021
- Primary completion1 Sep 2022
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- BioIntelliSense, Inc
- Responsible party
- Sponsor
- Investigators
- Glen Peterson, Principal investigator, Colorado Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180838
- Sponsor's protocol ID
- 20-2517.cc
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Data Capture of Elevated Temperature Data for Early Detection of Febrile Neutropenia in Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT05180838
- Acronym / sponsor ID
- 20-2517.cc
- Conditions
- Hematologic Malignancy
- Keywords
- Cytotoxic Chemotherapy, Stem cell transplant, CAR T-cell treatments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- BioIntelliSense, Inc
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 6 Jan 2022 (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.
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.
Detailed description
The BioIntelliSense BioSticker potentially offers a solution to these challenges through early and reliable detection of elevated temperature and perhaps other relevant physiologic changes. 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 (see https://biointellisense.com as well as attached documents on BioSticker instructions for a full description and use instructions). The BioSticker detects the following:
- Respiratory rate, heart rate at rest and skin temperature
- Body position, activity levels, sleep status
- High-resolution gait analysis and fall detection
- Symptomatic events
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioSticker | – | Device: BioStickerThis cohort will place BioStickers at least 3 days prior to completion of standard of care therapy and discharge home post therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| BioStickerThe 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 | Device | BioSticker |
Primary outcome
Reliability of BioSticker compared to self-check
Time frame: 28 days
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.
4 secondary outcomes
BioSticker Impact on Patient reported temperature
Time frame: 28 days
BioSticker Impact on Length of Hospitalization
Time frame: 28 days
BioSticker Impact on ICU transfers
Time frame: 28 days
BioSticker Impact on Delays in Chemotherapy
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Glen Peterson principal investigator
Colorado Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy, run by University of Colorado, Denver at 2 sites 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 10 inclusion and 4 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: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of BioSticker compared to self-check (time frame: 28 days). 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 21 Nov 2024.