Leptomeningeal MetastasisNCT07704034
Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal Metastasis
A study testing Calibration Phase and Stepped Wedge Intervention Phase in people with Leptomeningeal Metastasis, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This research study is for participants diagnosed with leptomeningeal metastasis disease (LMM), a condition where cancer has spread to the fluid and membranes surround the brain and spinal cord. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastasis
- What is being tested?
- Calibration Phase and Stepped Wedge Intervention Phase
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to 15 Nov 2027
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have leptomeningeal metastasis (LMM) diagnosed per clinical, imaging, and/or CSF/cytology criteria (cytology, flow cytometry, or circulating tumor DNA), arising from any solid or hematologic tumor primary.
- Participants must be undergoing active anti-cancer therapy (systemic, intrathecal, and/or radiation) or active surveillance for LMM.
- Age ≥18 years at the time of study enrollment. Because no safety or dosing data are available for wearable monitoring studies in children with LMM, participants under 18 years of age are excluded.
- Karnofsky Performance Status (KPS) ≥50 at time of study enrollment [See Appendix I], to ensure feasibility of wearing the device for ≥10 hours/day.
- Participants must have access to a compatible smartphone:
- iPhone running iOS 16 or higher and willingness to wear Apple Watch ≥10 hours/day; OR
- Android smartphone compatible with the study application and willingness to wear Samsung Galaxy Watch ≥10 hours/day.
- Ability to provide informed consent (or a legally authorized representative [LAR] is available and willing to provide consent on the participant's behalf, if appropriate).
Who cannot join
- Anticipated life expectancy <4 weeks at time of screening, per the treating physician.
- Severe dermatologic or musculoskeletal conditions precluding smartwatch wear (e.g., significant skin conditions on the wrist or forearm where the device will be placed, including tattoos that may substantially interfere with optical sensor function).
- Inability to adhere to study procedures after training, as assessed by the study team at enrollment.
- No access to a compatible smartphone (participant or caregiver) to interface with the watch application for symptom documentation and data transfer.
- Inability to give informed consent due to severe aphasia, severe cognitive impairment, or other language barrier, unless a legally authorized representative is available and willing to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Andrew Dhawan, MD, DPhil, 216-444-5322, dhawana@ccf.org
About this study
Official title: Wearable-Triggered Digital Safety Net for Real-Time Monitoring and Intervention in Leptomeningeal Metastasis
This research study is for participants diagnosed with leptomeningeal metastasis disease (LMM), a condition where cancer has spread to the fluid and membranes surround the brain and spinal cord. The purpose of this study is to find out whether a consumer Smartwatch can continuously monitor the participant's health and detect early signs of neurological decline and whether sending an automatic alert to the participant's doctor when a change is detected can help reduce the number of participant hospitalizations.
Read the detailed description
LMM is a condition where cancer has spread to the fluid and membranes surrounding the brain and spinal cord. It is a common complication of cancer and affects about 5-15% of all cancer patients. It causes rapid neurological decline and survival is usually around 6-12 months. LMM is treated with chemotherapy radiation, but this does not improve neurological function or quality of life. Many of the current assessments for LMM are not good detecting progression and symptoms are often missed.
There will be two parts to this study. Smartwatches will be used to continuously capture data such as gait stability, heart rate variability (HRV), step count, and sleep, which are affected by LMM. The first part of this study is to learn whether this can help detect early signs of neurological decline. The second part of this study will test whether sending an automatic alert to the participant's doctor when a change is detected can help reduce the amount of times the participants are admitted to the hospital unexpectedly.
- Conditions
- Leptomeningeal Metastasis
- Being tested
- Calibration Phase, Stepped Wedge Intervention Phase
- Keywords
- Brain and Nervous System
- Medical subject headings
- Meningeal Carcinomatosis, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calibration PhaseDevice
Apple Watch Series 6+ or Samsung Galaxy Watch 4+ worn 10+ hours/day for 4+ days/week for 6 months. Passive wearable data collection from in-house cross-platform app to find out patient-specific digital signal thresholds for neurological decline, symptom logging, daily sync reminders, and monthly EORTC-QLQ-C30 surveys.
Stepped Wedge Intervention PhaseDevice
Apple Watch Series 6+ or Samsung Galaxy Watch 4+ worn 10+ hours/day for 4+ days/week for 5 months. Active monitoring with alerts using the data collected from the in-house cross-platform app and sent to study neuro-oncologist.
| Study group | Role | What they receive |
|---|---|---|
| A - Crossover at month 2 | Experimental | Participants cross-over to Stepped Wedge Intervention Phase at month 2. Receives: Device: Calibration Phase; Device: Stepped Wedge Intervention Phase |
| B - Crossover at month 3 | Experimental | Participants cross-over to Stepped Wedge Intervention Phase at month 3. Receives: Device: Calibration Phase; Device: Stepped Wedge Intervention Phase |
| C - Crossover at month 4 | Experimental | Participants cross-over to Stepped Wedge Intervention Phase at month 4. Receives: Device: Calibration Phase; Device: Stepped Wedge Intervention Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicting Karnofsky Performance Scale (KPS) decline
Karnofsky Performance scale of 100-0. Sensitivity, specificity, Positive Predictive Value (PPV), and lead time of participant-specific thresholds. Assessed from calibration phase data if there is a greater than10-point KPS decline.
Measured: 6 months
Predicting neurological progression
Sensitivity, specificity, PPV, and lead time of participant-specific thresholds. Assessed from calibration phase data.
Measured: 6 months
Days in hospital per participant-month during silent monitoring periods
Taken from EMR by staff blinded to alert status. Defined as incidence rate ratios (IRRs) with 95% CIs using mixed-effects negative binomial regression.
Measured: 5 months
Days in hospital per participant-month during active alerting periods
Taken from EMR by staff blinded to alert status. Defined as incidence rate ratios (IRRs) with 95% CIs using mixed-effects negative binomial regression.
Measured: 5 months
Participant completion
80% or more of participants completing 3 months or more of active monitoring with median wear of 10 or more hours on 4 or more days/week
Measured: 5 months
Recruitment rate
number of participants enrolled within 9-12 months
Measured: 12 months
Dropout rate
Number of participants who do not complete study, assessed at study completion
Measured: 12 months
Alert pathway feasibility
Alert frequency per participant-month and proportion judged clinically relevant.
Measured: 5 months
Secondary outcomes (15)
Number of unplanned hospitalizations and ED visits per participant-month
Evaluate the efficacy of alert pathway in reducing unplanned hospitalization and ED visits. EMR review throughout Phase 2 during active vs. silent periods.
Measured: 5 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 ( EORTC-QLQ-C30) total and subscale scores
EORTC-QLQ-C30 is a 30 item validated questionnaire to determine the participant's quality of life. The questions are in a 4- point scale from 1 ("Not at all)" to 4 ("Very much"). A higher functional or global health score represents a higher quality of life, while a higher symptom score means a higher level of reported symptoms. Change in EORTC-QLQ-C30 will be measured from baseline at each time point.
Measured: 6 months
Progression-free survival (PFS)
Time from enrollment to first radiographic or clinical progression; assessed throughout treatment period
Measured: 12 months
Overall survival (OS)
Time from enrollment to death; assessed throughout treatment period and via medical record review
Measured: 12 months
Wearable data quantity across iOS and Android platforms
Assessed at each treatment visit per participant per month (mean, variance)
Measured: 12 months
Time from alert trigger to clinician-documented neurological progression
Evaluate the efficacy of alert pathway in reducing unplanned hospitalization and ED visits. EMR review throughout Phase 2 during active vs. silent periods.
Measured: 5 months
Wearable data quality across iOS and Android platforms
Assessed at each treatment visit per participant per month (mean, variance)
Measured: 12 months
Participant symptoms
Logged per type per participant per month. Assessed at each treatment visit
Measured: 12 months
Variance in accelerometry
This device is used to track changes in physical activity and sleep patterns. Assessed at study completion
Measured: 12 months
Variance in heart rate variability (HRV)
This device assess HRV, which is where the amount of time between heartbeats fluctuate slightly. The participant's heart data will be collected and used to see if there any changes from the participant's month 1 mean. Assessed at study completion
Measured: 12 months
Variance in gait metrics
This device assesses the speed, step length and asymmetry to see if changes these can predict any clinical events by days to weeks.
Measured: 12 months
Reasons for dropout
Collected via exit questionnaire at withdrawal or study completion
Measured: 12 months
Participant device wear
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL)
Measured: 12 months
Participant symptom logging
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
Measured: 12 months
Participant app usage
Collected via exit survey and structured questionnaires at each visit for participant reported quality of life (QOL).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startNov 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal MetastasisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Dhawan, MD, DPhil, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704034
- Sponsor's protocol ID
- CASE5326
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be shared in aggregate statistics. There is no universal standard for "raw" wearable data, making IPD sharing less useful without providing the entire technical infrastructure used by the original team. This trial is expected to generate massive datasets (gigabytes per participant). Curating, de-identifying, and hosting this volume of IPD for public access requires significant long-term funding and technical oversight that may be beyond the scope of this Investigator-Initiated Trial (IIT).