Clinical trial NCT05971277: Home And Locally Observed - Tracking (HALO-Trak)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Cancer
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients will be receiving standard of care therapies and will be recruited from Oncology clinics once a diagnosis of metastatic or haematological cancers has been established and patients meet all the inclusion criteria

Brief summary: 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.

Detailed description: The Investigators overarching aim is to determine the relationship between measures of physical performance status including heart rate and steps, health related quality of life (HRQoL) and genomic and immunogenomic phenotype on cancer outcomes in patients receiving chemotherapy or immunotherapy for haematological or metastatic cancer including renal (papillary, and RCC), breast, prostate, and other solid tumours. The primary objective is to test the feasibility of integrating diverse data streams (genomic, HR QoL and biometric) on a novel platform, capable of integrating data streams thus generating complex datasets for analyses using machine learning methodologies.

Secondary objectives will be to conduct exploratory analysis assessing the relationship between individual and combined data types and cancer outcomes.

Analysis using existing and novel computational models will be applied to the data to events in the acute and chronic setting that are common in patients diagnosed with cancer undergoing systemic therapy such as chemotherapy and immunotherapy. The outputs from this study will help inform future studies and trials designed to inform patients about their health status during cancer therapy

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Objective
timeFrame: one month to 52 weeks
measure: Remote monitoring data
timeFrame: one month to 52 weeks
measure: Biological sample data. This will include blood samples (30mls) maximum frequency will be monthly
timeFrame: one month to 52 weeks
measure: Clinical Outcome data
timeFrame: one month to 52 weeks
measure: Quality of life Questionnaire
timeFrame: one month to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCL London
Study officials:
References: