An observational study in Hematologic Malignancy, sponsored by University of Colorado, Denver. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by University of Colorado, Denver · Observational
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.
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:
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 20 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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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.
Exclusion Criteria:
This cohort will place BioStickers at least 3 days prior to completion of standard of care therapy and discharge home post therapy.
Device: BioSticker
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
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.
Time frame: 28 days
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.
Time frame: 28 days
BioSticker Impact on Length of Hospitalization
Hospitalization during the 28 days will be extracted from the medical record
Time frame: 28 days
BioSticker Impact on ICU transfers
ICU transfers during the 28 days will be extracted from the medical record
Time frame: 28 days
BioSticker Impact on Delays in Chemotherapy
Delays in chemotherapy during the 28 days will be extracted from the medical record
Time frame: 28 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver