Heuristics, Algorithms and Machine Learning: Evaluation & Testing in Radiation Therapy (Hamlet rt)

July 26, 2021 updated by: CCTU- Cancer Theme

Hamlet-RT: Heuristics, Algorithms and Machine Learning: Evaluation & Testing in Radiation Therapy

The Hamlet.rt study is a prospective data collection and patient questionnaire study for patients undergoing image-guided radiotherapy with curative intent.

The aim of the study is to use novel machine learning and mathematical techniques to build a model that can predict the risk of significant side effects from radiotherapy treatment for an individual patient: using calculations of normal tissue dose from radiotherapy treatment planning and patient baseline characteristics derived from image and non-image data, continuously updated as the patient is reviewed both during and after treatment.

A secondary goal of the project is to facilitate research in machine learning and medical image processing for radiation therapy through the creation of a discoverable and shared data resource for research use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Recruiting
        • Cambridge University Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Raj Dr. Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults suitable for radical image-guided radiotherapy with Prostate, Head & Neck, Brain, or Lung Cancer. The variation in conditions is based on the requirements of Machine Learning algorithms requiring high levels of clinical applicability, which depends on the quality and quantity of the input data available. The input data set therefore should adequately encompass the variation in anatomy encountered in the population.

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study
  • Male or Female
  • Aged 18 years or older
  • Diagnosed with primary prostate cancer, head and neck cancer, lung cancer, or brain tumour
  • Treated with curative intent
  • Suitable for radical image guided radiotherapy
  • WHO ECOG performance status 0 or 1
  • Expected survival of 18 months or more

Exclusion Criteria:

  • Participant is not willing or able to complete the protocol-stated requirements of the study, e.g. accessing & completing web-based long-term follow-up questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Prostate Cancer
Adults suitable for radical image-guided radiotherapy for their Prostate cancer, approximately 170 patients Components from RTOG, LENT SOM(A), RMH symptom scale and UCLA PCI (prostate cancer index) questionnaires will be used.
Radiation: Radical Image-Guided Radiotherapy
Questionnaires administered will monitor the clinical toxicity experienced by each patient up to 5 years post radiotherapy
Head & Neck Cancer
Adults suitable for radical image-guided radiotherapy for their Head & Neck cancer, approximately 140 patients. Components from CTCAE v3, LENT SOM(A), EORTC QLQ H+N35 & Modified xerostomia questionnaires will be used.
Radiation: Radical Image-Guided Radiotherapy
Questionnaires administered will monitor the clinical toxicity experienced by each patient up to 5 years post radiotherapy
Central Nervous System Tumours
Adults suitable for radical image-guided radiotherapy for their CNS tumour, as many patients recruited as possible. Components from RTOG, LENT SOM(A), Folstein mini mental state examination & Generalised activites of daily living scale (G-ADL) questionnaires will be used.
Radiation: Radical Image-Guided Radiotherapy
Questionnaires administered will monitor the clinical toxicity experienced by each patient up to 5 years post radiotherapy
Lung Cancer
Adults suitable for radical image-guided radiotherapy for their Lung cancer, as many patients recruited as possible. Components from RTOG & LENT SOM(A) questionnaires will be used.
Radiation: Radical Image-Guided Radiotherapy
Questionnaires administered will monitor the clinical toxicity experienced by each patient up to 5 years post radiotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Machine Learning Modelling
Time Frame: 8 years from FPFV
Characterise machine learning models for the four disease sites. Developing machine learning algorithms for autosegmentation of normal tissue anatomy, and to extend machine learning algorithms to identify and segment normal tissue structures in cone beam CT images, and to utilise the ML segmentations to evaluate image signatures correlated with treatment toxicity
8 years from FPFV
Predictive Modelling
Time Frame: 8 years from FPFV
Predict performance matches with published techniques. Combining the machine learning models in outcome 1, with pre-treatment assessment data and on-treatment quantitative assessments in outcome 3 for the construction and evaluation of a predictive mathematical model
8 years from FPFV
Clinical Toxicity Evaluation
Time Frame: 8 years from FPFV
Evaluation of the clinical toxicity experienced by each patient up to 5 years post radiotherapy to inform the predictive models in outcome 2
8 years from FPFV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CCTU- Cancer Theme

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Cambridge
Microsoft Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raj Dr. Jena, Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge
  • Principal Investigator: Suzanne Miller, Cambridge University Hospitals NHS Foundation Trust
  • Principal Investigator: Amy Bates, Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Hamlet.rt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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