Actively Recruiting

Age: 18Years +
All Genders
ID03378856

Partnership Initiative for Evaluating New Technology in Radiotherapy A Large Observational Cohort Study on Radiation Effects and Outcomes

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-12-20

1500

Participants Needed

5

Research Sites

413 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to build infrastructure to systematically collect clinical data, patient-reported outcomes, and imaging data from patients receiving standard radiotherapy or brachytherapy. It focuses on patients with cancer and radiotherapy side effects, using a prospective cohort design to better understand radiation effects and long-term outcomes. The study also serves as a platform for multiple randomized controlled trials (RCTs) using an innovative cohort multiple randomized controlled trial (cmRCT) design. Participants receive their usual radiotherapy care while giving informed consent for data collection and possible random selection for future experimental interventions within the cohort. Patient-reported outcomes are collected at baseline and regular intervals during follow-up. Participants selected for experimental interventions provide additional consent, while those not selected may serve as controls without further notification. After each RCT, all cohort members receive summarized trial results. Throughout the study, researchers collect and analyze imaging data, clinical outcomes, and patient reports to compare treatment effects and understand dose-response relationships. The study tracks accrual rates over two years and aims to provide a control cohort for comparative effectiveness research. Participant involvement includes ongoing data collection and follow-up assessments, supporting long-term monitoring of radiotherapy impacts and technological innovations.

CONDITIONS

Official Title

Evaluation of Technological Innovation in Radiotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed consent
  • Receiving radiotherapy or brachytherapy
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 5 locations

1

London Health Regional Cancer Centre

London, Ontario, Canada

Not Yet Recruiting

2

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Not Yet Recruiting

3

Centre de santé et de services sociaux de Laval

Laval, Quebec, Canada

Actively Recruiting

4

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Actively Recruiting

5

CHUQ

Québec, Quebec, Canada

Not Yet Recruiting

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Research Team

C

Cynthia Ménard, MD, M.Sc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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Published Research Related To This Trial

Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation.

Philippe Giguère, Houda Bahig, Sydney Westra...

https://pubmed.ncbi.nlm.nih.gov/42032732

PSMA-PET/CT-Guided Intensification of Radiation Therapy for Prostate Cancer (PSMAgRT): Findings of Detection Rate, Effect on Cancer Management, and Early Toxicity From a Phase 2 Randomized Controlled Trial.

Claire Petit, Guila Delouya, Daniel Taussky...

https://pubmed.ncbi.nlm.nih.gov/36639035

Focal HDR brachytherapy boost to stereotactic radiotherapy (fBTsRT) for prostate cancer: a phase II randomized controlled trial.

C Belliveau, M Barkati, G Delouya...

https://pubmed.ncbi.nlm.nih.gov/36494834

Effect of magnetic resonance imaging pre-processing on the performance of model-based prostate tumor probability mapping.

Stephanie Alley, Edward Jackson, Damien Olivié...

https://pubmed.ncbi.nlm.nih.gov/36223780
Partnership Initiative for Evaluating New Technology in Radiotherapy A Large Observational Cohort Study on Radiation Effects and Outcomes | DecenTrialz