Clinical trial · Observational
Home And Locally Observed - Tracking (HALO-Trak)
Proof of Concept (POC) Prospective Observational Study to Test a Framework for Integration of Data Streams, Including Molecular Genomic Markers and Wearable Device Data in Patients Receiving Chemotherapy for Advanced Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to collect biometric, HRQoL, immune response and genomic data continuously and intermittently during and after chemo or immunotherapy for the generation of a complex dataset using a platform which can aggregate different types of data collected over a time period and, to test the potential for analysis within and across data sets with linkage to clinical outcomes. The framework will have capabilities to integrate data from electronic medical records (EMRs) such as Epic, as well as digital streams including sensor, genomic, imaging and pathology. Such a platform can realise the potential for machine learning (ML) methodologies to address important cancer outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Halo Wearable data device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Primary Objective
- timeFrame
- one month to 52 weeks
- description
- To measure feasibility of data collection longitudinally in a patient cohort undergoing systemic therapy for metastatic or haematological cancer.
- measure
- Remote monitoring data
- timeFrame
- one month to 52 weeks
- description
- To collect activity (steps) and heart rate data. This will be collected using the Ethera Wellness app which participants will download onto their smartphone devices.
- measure
- Biological sample data. This will include blood samples (30mls) maximum frequency will be monthly
- timeFrame
- one month to 52 weeks
- description
- This will include blood samples (30mls) and stool samples maximum frequency will be monthly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ● A diagnosis of a metastatic or haematological cancer undergoing systemic therapy * Undergoing at least 1 planned cycle of chemotherapy or immunotherapy, according to standard of care practices. * Ability to understand and the willingness to sign a written informed consent. * Able to ambulate without assistance or walking aid. * Have an Android or iOS phone and willing to download the Ethera app Exclusion Criteria: * ● Physical disabilities that preclude daily walking * Inability to provide informed consent. * Unable to use and operate the Ethera Health Monitoring Smartphone App. (Apple or Android) * Medical or psychiatric condition which in the investigator's opinion would affect the successful completion of the study.
References
Publications (0)
Data not yet available