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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03378856
Other study ID # 17.032
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date October 2025

Study information

Verified date September 2023
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact Cynthia Ménard, MD, M.Sc
Phone 514-890-8254
Email Cynthia.Menard@umontreal.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ability to provide informed consent - Receiving radiotherapy or brachytherapy Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Centre de santé et de services sociaux de Laval Laval Quebec
Canada London Health Regional Cancer Centre London Ontario
Canada Centre Hospitalier de l'Université de Montréal Montréal Quebec
Canada CHUQ Québec Quebec
Canada Princess Margaret Cancer Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accrual rates Determine feasibility of achieving high accural rates (greater than 80%) with this approach. 2 years
Secondary Number of cmRCT trials activated Measure if success would be the activation of 2 or more trials in the time frame. 2 years
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