An observational study in Cancer and Radiotherapy Side Effect, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 9 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients receiving standard-care radiotherapy at CHUM
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Accrual rates
Determine feasibility of achieving high accural rates (greater than 80%) with this approach.
Time frame: 2 years
Number of cmRCT trials activated
Measure if success would be the activation of 2 or more trials in the time frame.
Time frame: 2 years
Started Nov 2017 (actual). Primary completion is estimated for Oct 2040, 275 months after the start.
Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's planned 275 months is above that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre hospitalier de l'Université de Montréal (CHUM) →