Evaluation of Technological Innovation in Radiotherapy (PERA)

December 18, 2024 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Partnership Initiative for the Evaluation of Technological Innovation in Radiotherapy

Prospective cohort study of patients receiving standard-care radiotherapy is paramount to a better understanding of radiation effects and longterm outcomes.

The primary objective is to determine the feasibility of establishing infrastructure to systematically collect clinical data, patient-reported outcomes, and imaging data from daily radiotherapy practice.

Secondary objectives are to provide a control cohort for comparative effectiveness research of investigational interventions through a cmRCT design; compare imaging features with clinical outcomes; understand dose-effect relationships; quantify imaging quality metrics.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study consists of an effort to develop infrastructure that will support systematic collection of data from daily radiotherapy practice. At the core, PERA is a large observational cohort study, serving as a multiple cohort randomized trial and image banking facility. It includes consent for the collection of imaging data, patient-reported outcomes, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT).

The basis of this design is a prospective cohort of participants receiving care as usual, who give informed consent for cohort participation.

Participants can furthermore be asked for informed consent to be randomized in future RCTs conducted within the cohort. Participants are informed that they will be offered an experimental intervention if they are randomly selected. They are also informed that they otherwise might serve as controls without being notified and that their data can be used in a trial context. For each participant in the cohort, PROs are captured at baseline and at regular intervals during follow-up. Within this cohort, multiple RCTs can be conducted. The design is especially attractive for clinical research areas with rapid evolution of technology, and for highly desired or expensive interventions.

In the first stage, at entry into the cohort, all potential participants are asked for their informed consent to participate in a cohort study and broad consent to be either randomly selected to be approached for experimental interventions or to serve as control without further notice during participation in the cohort. In a second stage, at the initiation of an RCT within the cohort, informed consent to receive the intervention is then only sought in those randomly selected for the intervention arm. At the third stage, after completion of each RCT, all cohort participants receive aggregate disclosure of trial results.

Study Type

Observational

Enrollment (Estimated)

1500

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 Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • Not yet recruiting
        • London Health Regional Cancer Centre
        • Contact:
      • Toronto, Ontario, Canada
    • Quebec
      • Laval, Quebec, Canada
        • Recruiting
        • Centre de santé et de services sociaux de Laval
        • Contact:
          • Marie-Andrée Fortin, MD
      • Montréal, Quebec, Canada
      • Québec, Quebec, Canada

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients receiving standard-care radiotherapy at CHUM

Description

Inclusion Criteria:

  • Ability to provide informed consent
  • Receiving radiotherapy or brachytherapy

Exclusion Criteria:

-

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accrual rates
Time Frame: 2 years
Determine feasibility of achieving high accural rates (greater than 80%) with this approach.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cmRCT trials activated
Time Frame: 2 years
Measure if success would be the activation of 2 or more trials in the time frame.
2 years

Collaborators and Investigators

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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2017

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 17.032

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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