Home And Locally Observed - Tracking (HALO-Trak)

Advanced Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971277
• Other study ID #: 150745
• Secondary ID: 312296
• Status: Recruiting
• Start date: January 30, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: January 2023
• Source: University College, London
• Contact: John D Kelly, Professor
• Phone: 07549152902
• Email: j.d.kelly[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Device:
• Halo Wearable data device
A wrist-worn tracker with heart-rate monitor and pedometer (step counter), as well as a mobile app.

Locations

Country	Name	City	State
United Kingdom	UCL London	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective	To measure feasibility of data collection longitudinally in a patient cohort undergoing systemic therapy for metastatic or haematological cancer.	one month to 52 weeks
Primary	Remote monitoring data	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.	one month to 52 weeks
Primary	Biological sample data. This will include blood samples (30mls) maximum frequency will be monthly	This will include blood samples (30mls) and stool samples maximum frequency will be monthly	one month to 52 weeks
Primary	Clinical Outcome data	Data will be collected via an electronic case report form-	one month to 52 weeks
Primary	Quality of life Questionnaire	EORTC QLQ C30- questionnaire will be collected monthly	one month to 52 weeks