AzTrials
AzTrials

CancerPERANCT03378856

Evaluation of Technological Innovation in Radiotherapy

An observational study of Cancer and Radiotherapy Side Effect, run by Centre hospitalier de l'Université de Montréal (CHUM) at 9 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Radiotherapy Side Effect
How many people
1,500 participants
Where
9 sitesCanada
Study dates
1 Nov 2017to Oct 2040
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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: Patients receiving standard-care radiotherapy at CHUM

Who may be able to join

  • Ability to provide informed consent
  • Receiving radiotherapy or brachytherapy

Who cannot join

  • -

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cynthia Ménard, MD, M.Sc contact

514-890-8254

Cynthia.Menard@umontreal.ca

9 sites in 1 country

Canada9 sites, 9 recruiting

  • BC Cancer - Kelowna

    Kelowna, British Columbia

    Jennifer Petterson, Petterson, jennifer.petterson@bccancer.bc

    Katie Jasper, MD

    Recruiting

  • CISSS de Laval - Hôpital de la Cité-de-la-Santé

    Laval, Quebec

    Imane Benmouhoub, imane.benmouhoub.cissslav@ssss.gouv.qc.ca

    Danny Duplan, MD

    Recruiting

  • London Health Regional Cancer Centre

    London, Ontario, N6C 2R5

    Karen Eddy, (519) 685-8500, karen.eddy@lhsc.on.ca

    Pencilla Lang, MD

    Recruiting

  • Research Institute of the McGill University Health Center

    Montreal, Quebec, H3H 2R9

    Marianna Perna, 514-934-1934, marianna.perna@muhc.mcgill.ca

    Fabio Cury, MD

    Recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec

    Eva Nkurunziza, 514-890-8000 ext. 30898, eva-sabrina.nkurunziza.chum@ssss.gouv.qc.ca

    Cynthia Ménard, MD

    Recruiting

  • CHU de Québec - Université Laval

    Québec, Quebec

    Alexandre Villeneuve-Gauthier, 4185254444, Alexandre.Villeneuve-Gauthier@chudequebec.ca

    Eric Vigneault, MD

    Recruiting

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

    514-934-1934

    Amir Safavi, MD

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario

    Ebrahim Aslani, (416) 946-6560, ebrahim.aslani@uhn.ca

    Philip Wong

    Recruiting

  • BC Cancer - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Jackie Cao, (250) 712-3900, sijia.cao@bccancer.bc.ca

    Srinivas Raman, MD

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Medical subject headings
Neoplasms, Radiation Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accrual rates

    Determine feasibility of achieving high accural rates (greater than 80%) with this approach.

    Measured: 2 years

Secondary outcomes (1)

  1. Number of cmRCT trials activated

    Measure if success would be the activation of 2 or more trials in the time frame.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2017
  2. Study start1 Nov 2017
  3. Primary completionOct 2040 (estimated)
  4. Study completionOct 2040 (estimated)

Resources

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
1,500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03378856
Sponsor's protocol ID
17.032
Acronym
PERA
Status last verified
Aug 2026
First submitted
12 Dec 2017
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0.

    PubMed 42032732

  • Petit C, Delouya G, Taussky D, Barkati M, Lambert C, Beauchemin MC, Clavel S, Mok G, Pare AG, Nguyen TV, Duplan D, Keu KV, Saad F, Juneau D, Menard C. 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. Int J Radiat Oncol Biol Phys. 2023 Jul 15;116(4):779-787. doi: 10.1016/j.ijrobp.2022.12.055. Epub 2023 Jan 11.

    PubMed 36639035

  • Belliveau C, Barkati M, Delouya G, Taussky D, Beauchemin MC, Lambert C, Beaulieu L, Beliveau-Nadeau D, Nicolas B, Carrier JF, Vigneault E, Menard C. Focal HDR brachytherapy boost to stereotactic radiotherapy (fBTsRT) for prostate cancer: a phase II randomized controlled trial. Radiat Oncol. 2022 Dec 9;17(1):203. doi: 10.1186/s13014-022-02173-5.

    PubMed 36494834

  • Alley S, Jackson E, Olivie D, Van der Heide UA, Menard C, Kadoury S. Effect of magnetic resonance imaging pre-processing on the performance of model-based prostate tumor probability mapping. Phys Med Biol. 2022 Dec 13;67(24). doi: 10.1088/1361-6560/ac99b4.

    PubMed 36223780

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer and Radiotherapy Side Effect, run by Centre hospitalier de l'Université de Montréal (CHUM) at 9 sites in Canada.

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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cynthia Ménard, MD, M.Sc (514-890-8254, Cynthia.Menard@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accrual rates (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03378856, which also lists 4 linked publications.

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 1 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in