Advanced CancerHALO-TrakNCT05971277
Home And Locally Observed - Tracking (HALO-Trak)
An observational study of Advanced Cancer, run by University College, London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Halo Wearable data device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2023to 1 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- ● 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
Who cannot join
- ● 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
UCL London
London, W1W 7TY
John D Kelly, Professor, 075497152902, j.d.kelly@ucl.ac.uk
Hazel McBain, Snr Nurse, 07342976009, hazelmcbain@nhs.net
About this study
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
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.
Read the 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
- Conditions
- Advanced Cancer
- Being tested
- Halo Wearable data device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halo Wearable data deviceDevice
A wrist-worn tracker with heart-rate monitor and pedometer (step counter), as well as a mobile app.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
To measure feasibility of data collection longitudinally in a patient cohort undergoing systemic therapy for metastatic or haematological cancer.
Measured: one month to 52 weeks
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.
Measured: one month to 52 weeks
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
Measured: one month to 52 weeks
Clinical Outcome data
Data will be collected via an electronic case report form-
Measured: one month to 52 weeks
Quality of life Questionnaire
EORTC QLQ C30- questionnaire will be collected monthly
Measured: one month to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start30 Jan 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971277
- Sponsor's protocol ID
- 150745
- Other IDs
- 312296
- Acronym
- HALO-Trak
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05971277
- Acronym / sponsor ID
- HALO-Trak / 150745
- Conditions
- Advanced Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 Aug 2023 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- ● A diagnosis of a metastatic or haematological cancer undergoing systemic therapy
Key exclusion criteria (4 listed)
- ● Physical disabilities that preclude daily walking
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 |
|---|---|---|
| Halo Wearable data deviceA wrist-worn tracker with heart-rate monitor and pedometer (step counter), as well as a mobile app. | Device | – |
Primary outcome
Primary Objective
Time frame: one month to 52 weeks
To measure feasibility of data collection longitudinally in a patient cohort undergoing systemic therapy for metastatic or haematological cancer.
Remote monitoring data
Time frame: one month to 52 weeks
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.
Biological sample data. This will include blood samples (30mls) maximum frequency will be monthly
Time frame: one month to 52 weeks
This will include blood samples (30mls) and stool samples maximum frequency will be monthly
Clinical Outcome data
Time frame: one month to 52 weeks
Data will be collected via an electronic case report form-
Quality of life Questionnaire
Time frame: one month to 52 weeks
EORTC QLQ C30- questionnaire will be collected monthly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
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 Advanced Cancer, run by University College, London at 1 site in United Kingdom.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John D Kelly, Professor (07549152902, j.d.kelly@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: one month to 52 weeks). The study lists 5 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 2 Aug 2023.