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Evaluation of Technological Innovation in Radiotherapy (PERA)

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ClinicalTrials.gov Identifier: NCT03378856
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief 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.


Condition or disease
Cancer Radiotherapy Side Effect

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Partnership Initiative for the Evaluation of Technological Innovation in Radiotherapy
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021



Primary Outcome Measures :
  1. Accrual rates [ Time Frame: 2 years ]
    Determine feasibility of achieving high accural rates (greater than 80%) with this approach.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving standard-care radiotherapy at CHUM
Criteria

Inclusion Criteria:

  • Ability to provide informed consent
  • Receiving radiotherapy or brachytherapy

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378856


Contacts
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Contact: Cynthia Ménard, MD, M.Sc 514-890-8254 Cynthia.Menard@umontreal.ca

Locations
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Canada, Quebec
Centre de santé et de services sociaux de Laval Not yet recruiting
Laval, Quebec, Canada
Contact: Marie-Andrée Fortin, MD         
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada
Contact: Diane Trudel    514-890-8000 ext 26906    diane.dt.trudel.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)

Additional Information:

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03378856     History of Changes
Other Study ID Numbers: 17.032
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No