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

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05200429

Collaborator

(none)

500

Enrollment

Locations

Anticipated Duration (Months)

250

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Drug: Trikafta

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

To examine the long-term pulmonary and nutritional effects of CFTR modulators. [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. [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. [5 years]
To establish the benefits of CFTR modulators compared to propensity-score matched historic CF populations followed in the Canadian CF registry. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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