Canadian Observational Study Evaluating the Long-term IMPACT of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators on People With CF (Can-IMPACT CF)

January 6, 2022 updated by: Jonathan Rayment, University of British Columbia

Canadian Observational Study Evaluating the Long-term IMPACT of CFTR (Can-IMPACT CF)

This observational study intends to investigate health trends and data in cystic fibrosis patients all across Canada that are receiving modulator treatment so researchers can determine if CFTR treatments are effective over a long period of time and if so, which treatments work best for each individual. The study will collect clinical data from routine standard of care, patient reported outcomes via survey data and samples for a biobank.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

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 Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Recruiting
        • British Columbia Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan Rayment, MDCM

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All people with CF who do not have any known contraindications to CFTR modulator therapy and will be initiated on CFTR modulator therapy by their treating physician as part of clinical care are eligible and will be asked to participate in this study

Description

Inclusion Criteria:

  • Prescribed a CFTR modulator therapy and planning to commence modulator therapy within 30 days OR planning to switch modulator therapies within 30 days
  • Participates in the Canadian Cystic Fibrosis Registry (CCFR)
  • Informed consent by participant, or parent/legal guardian or assent

Exclusion Criteria:

  • Known contraindications to CFTR modulator therapy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-Therapy Participants
All CF people with CF who do not have any known contraindications to CFTR modulator therapy and will be initiated on CFTR modulator therapy by their treating physician as part of clinical care are eligible and will be asked to participate in this study.
Drug: Trikafta
Highly Effective CFTR Modulator Therapy
Other Names:
  • Elexacaftor/Tezacaftor/Ivacaftor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To examine the long-term pulmonary and nutritional effects of CFTR modulators.
Time Frame: 5 years
5 years
To assess the long-term impact of CFTR modulators on patient-reported outcome measures including quality of life, disease burden, and physical activity.
Time Frame: 5 years
5 years
To establish a bio-repository to enable further investigations of the effectiveness of CFTR modulator therapies on biological markers and predictors of response.
Time Frame: 5 years
5 years
To establish the benefits of CFTR modulators compared to propensity-score matched historic CF populations followed in the Canadian CF registry.
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Jonathan Rayment, MDCM, University of British Columbia
  • Principal Investigator: Bradley Quon, MD, University of British Columbia

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, 2021

Primary Completion (Anticipated)

December 31, 2027

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21-01707

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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