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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04060706
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

CCTU- Cancer Theme
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Raj Dr. JenaSuzanne MillerAmy Bates
Principal Investigator Affiliation Cambridge University Hospitals NHS Foundation Trust & the University of CambridgeCambridge University Hospitals NHS Foundation TrustCambridge University Hospitals NHS Foundation Trust
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cancer
Arms & Interventions

Arms

: 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.

: 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.

: 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.

: 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.

Interventions

Radiation: - Radical Image-Guided Radiotherapy

Questionnaires administered will monitor the clinical toxicity experienced by each patient up to 5 years post radiotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cambridge, Cambridgeshire, United Kingdom

Status

Recruiting

Address

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ

Site Contact

Amy Bates

[email protected]

01223 256296 #256296

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