Acute Lymphoblastic LeukemiaNCT04322084
Continuous Ambulatory Monitoring to Predict Elevated Risk of Infection in Children With Lymphoblastic Leukemia Undergoing Induction Chemotherapy (CAMPER-ALL)
An observational study of Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Acute lymphoblastic leukemia (ALL) is the most common cancer of childhood and long-term survival has risen to above 90%, but 1-4% of treated patients die from infections. Early detection and treatment of infection can improve these outcomes by preventing increased severity and death. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Wearable Sensors
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2024to Jul 2025
- 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 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All Participants who meet eligibility criteria and consent to enrollment on the study.
Who may be able to join
- Between 5 and 25 years of age at time of study enrollment
- Undergoing induction therapy for acute lymphoblastic leukemia at St. Jude
- Expected to remain outpatient during periods of high infection risk
Who cannot join
- Documented allergy to components of the device (Empatica E4: elemental silver, polyurethane, or polycarbonate; TempTraq: latex-free adhesive).
- Any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
- Current fever or sepsis at time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Acute lymphoblastic leukemia (ALL) is the most common cancer of childhood and long-term survival has risen to above 90%, but 1-4% of treated patients die from infections. Early detection and treatment of infection can improve these outcomes by preventing increased severity and death. This study aims to determine whether continuous analysis of information from wearable devices (Like a watch and sticky patch) that measure temperature, pulse rate, oxygen level, and other similar information can predict infection before it is apparent to the patient or caregiver. About 65 patients will be enrolled and will wear these devices for 10 days; during that time the information will be recorded, but not available. After completion, information collected immediately before infection will be compared to other times to identify features that predict infections.
Read the detailed description
Primary Objectives (Feasibility Phase) To determine the feasibility of non-invasive collection of continuous physiological data in children with acute lymphoblastic leukemia during outpatient treatment.
(Completion Phase) To develop competing sepsis prediction algorithms using continuous physiological data during outpatient treatment in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
Secondary Objectives To estimate the PPV and NPV of competing sepsis prediction algorithms using continuous physiological data for prediction of fever and sepsis in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
To estimate the frequency of undocumented fever episodes in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
To estimate the time from detection of fever or sepsis by a wearable device to identification by standard practice in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
This study aims to determine whether continuous analysis of those biosignals in children treated for ALL can predict early onset of sepsis. To collect those biosignals, we combine two wearable sensors, namely TempTraq, an adhesive temperature sensor, and Empatica E4, a wearable physiological monitoring device.
Data will be collected during two selected high-risk 5-day periods of induction therapy for acute lymphoblastic leukemia. Statistical models will be applied and a series of validation methodologies will be developed to arrive at an optimal predictive model for subsequent external validation .
This study will use a two-stage design. The initial stage (the feasibility phase) will evaluate the feasibility of data collection, and the second stage (the completion phase) will provide sufficient data for the development of predictive models and the estimation of the sensitivity and specificity of these models .
Feasibility Phase
The feasibility phase of the study will comprise the first 10 study participants, including at least 3 in each age group (5 to <10 years, and >/= 10 years). The aim of this stage is to estimate the proportion of time that continuous monitoring data are available, and these results will determine whether the study progresses to the completion phase
Completion Phase
The Completion Phase will comprise approximately 55 participants. Enrollment will continue until:
- A total of 15 participants have experienced a fever or sepsis event for the prediction model, and
- At least 15 participants have completed the study without experiencing a fever or sepsis event.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Wearable Sensors
- Keywords
- ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable SensorsOther
To develop predictive algorithms that identify early onset of sepsis in children being treated for ALL. This study will use a two-stage design. The initial stage (the feasibility phase) will evaluate the feasibility of data collection, and the second stage (the completion phase) will provide data for the design of predictive models.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants will be enrolled during induction therapy for ALL, before the first high-risk period of treatment, and will contribute data for two 5-day periods of continuous monitoring. Receives: Other: Wearable Sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility phase
The aim of this stage is to estimate the proportion of time that continuous monitoring data are available, and these results will determine whether the study progresses to the completion phase.
Measured: 5 weeks
Completion phase
This phase will provide sufficient data to develop competing sepsis prediction algorithms using continuous physiologic data for cross-validation.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study startSep 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: The study was activated at the onset of the COVID pandemic. At that time voluntary, non-therapeutic research was placed on hold. Now the technology has evolved and have elected to forego this protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Wolf, MBBS, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322084
- Sponsor's protocol ID
- CAMPER-ALL
- Other IDs
- NCI-2011-01222
- Status last verified
- Sep 2024
- First submitted
- 23 Mar 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Ambulatory Monitoring to Predict Elevated Risk of Infection in Children With Lymphoblastic Leukemia Undergoing Induction Chemotherapy (CAMPER-ALL)
- ClinicalTrials.gov ID
- NCT04322084
- Acronym / sponsor ID
- CAMPER-ALL
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was activated at the onset of the COVID pandemic. At that time voluntary, non-therapeutic research was placed on hold. Now the technology has evolved and have elected to forego this protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 26 Mar 2020 (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.
Acute lymphoblastic leukemia (ALL) is the most common cancer of childhood and long-term survival has risen to above 90%, but 1-4% of treated patients die from infections. Early detection and treatment of infection can improve these outcomes by preventing increased severity and death. This study aims to determine whether continuous analysis of information from wearable devices (Like a watch and sticky patch) that measure temperature, pulse rate, oxygen level, and other similar information can predict infection before it is apparent to the patient or caregiver. About 65 patients will be enrolled and will wear these devices for 10 days; during that time the information will be recorded, but not available. After completion, information collected immediately before infection will be compared to other times to identify features that predict infections.
Detailed description
Primary Objectives (Feasibility Phase) To determine the feasibility of non-invasive collection of continuous physiological data in children with acute lymphoblastic leukemia during outpatient treatment.
(Completion Phase) To develop competing sepsis prediction algorithms using continuous physiological data during outpatient treatment in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
Secondary Objectives To estimate the PPV and NPV of competing sepsis prediction algorithms using continuous physiological data for prediction of fever and sepsis in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
To estimate the frequency of undocumented fever episodes in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
To estimate the time from detection of fever or sepsis by a wearable device to identification by standard practice in children with acute lymphoblastic leukemia during high-risk periods of induction therapy.
This study aims to determine whether continuous analysis of those biosignals in children treated for ALL can predict early onset of sepsis. To collect those biosignals, we combine two wearable sensors, namely TempTraq, an adhesive temperature sensor, and Empatica E4, a wearable physiological monitoring device.
Data will be collected during two selected high-risk 5-day periods of induction therapy for acute lymphoblastic leukemia. Statistical models will be applied and a series of validation methodologies will be developed to arrive at an optimal predictive model for subsequent external validation .
This study will use a two-stage design. The initial stage (the feasibility phase) will evaluate the feasibility of data collection, and the second stage (the completion phase) will provide sufficient data for the development of predictive models and the estimation of the sensitivity and specificity of these models .
Feasibility Phase
The feasibility phase of the study will comprise the first 10 study participants, including at least 3 in each age group (5 to <10 years, and >/= 10 years). The aim of this stage is to estimate the proportion of time that continuous monitoring data are available, and these results will determine whether the study progresses to the completion phase
Completion Phase
The Completion Phase will comprise approximately 55 participants. Enrollment will continue until:
- A total of 15 participants have experienced a fever or sepsis event for the prediction model, and
- At least 15 participants have completed the study without experiencing a fever or sepsis event.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Wearable SensorsParticipants will be enrolled during induction therapy for ALL, before the first high-risk period of treatment, and will contribute data for two 5-day periods of continuous monitoring. |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All Participants who meet eligibility criteria and consent to enrollment on the study.
Key inclusion criteria (3 listed)
- Between 5 and 25 years of age at time of study enrollment
- Undergoing induction therapy for acute lymphoblastic leukemia at St. Jude
- Expected to remain outpatient during periods of high infection risk
Key exclusion criteria (3 listed)
- Documented allergy to components of the device (Empatica E4: elemental silver, polyurethane, or polycarbonate; TempTraq: latex-free adhesive).
- Any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
- Current fever or sepsis at time of enrollment
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 |
|---|---|---|
| Wearable SensorsTo develop predictive algorithms that identify early onset of sepsis in children being treated for ALL. This study will use a two-stage design. The initial stage (the feasibility phase) will evaluate the feasibility of data collection, and the second stage (the completion phase) will provide data for the design of predictive models. | Other | Participants |
Primary outcome
Feasibility phase
Time frame: 5 weeks
The aim of this stage is to estimate the proportion of time that continuous monitoring data are available, and these results will determine whether the study progresses to the completion phase.
Completion phase
Time frame: 5 weeks
This phase will provide sufficient data to develop competing sepsis prediction algorithms using continuous physiologic data for cross-validation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Joshua Wolf, MBBS, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility phase (time frame: 5 weeks). The study lists 2 primary outcomes in all. 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 25 Sep 2024.