Cystic FibrosisCan-IMPACT CFNCT05200429
Canadian Observational Study Evaluating the Long-term IMPACT of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators on People With CF
An observational study of Cystic Fibrosis, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Trikafta
- How many people
- 500 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Nov 2021to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Known contraindications to CFTR modulator therapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
Britney Ha, 604-875-2345 ext. 7606, Britney.Ha@cw.bc.ca
Vanessa Diamond, 604-875-2345 ext. 7606, vanessa.diamond@bcchr.ca
- Recruiting
St Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Ronak Salamat, 604-806-9158, rsalamatravandi@providencehealth.bc.ca
Taryn Leach, tleach@providencehealth.bc.ca
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Trikafta
- Keywords
- Trikafta, Cystic Fibrosis, CFTR Modulator Therapy, Respiratory Disease
- Medical subject headings
- Cystic Fibrosis, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrikaftaDrug
Also called Elexacaftor/Tezacaftor/Ivacaftor
Highly Effective CFTR Modulator Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Trikafta |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the long-term pulmonary and nutritional effects of CFTR modulators.
Measured: 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.
Measured: 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.
Measured: 5 years
To establish the benefits of CFTR modulators compared to propensity-score matched historic CF populations followed in the Canadian CF registry.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Nov 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Rayment, University of British Columbia
- Investigators
- Jonathan Rayment, MDCM, Principal investigator, University of British ColumbiaBradley Quon, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200429
- Sponsor's protocol ID
- H21-01707
- Acronym
- Can-IMPACT CF
- Status last verified
- Jan 2022
- First submitted
- 6 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Observational Study Evaluating the Long-term IMPACT of CFTR (Can-IMPACT CF)
- ClinicalTrials.gov ID
- NCT05200429
- Acronym / sponsor ID
- Can-IMPACT CF / H21-01707
- Conditions
- Cystic Fibrosis
- Keywords
- Trikafta, Cystic Fibrosis, CFTR Modulator Therapy, Respiratory Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-Therapy Participants | – | Drug: TrikaftaAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Known contraindications to CFTR modulator therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrikaftaAlso: Elexacaftor/Tezacaftor/IvacaftorHighly Effective CFTR Modulator Therapy | Drug | Pre-Therapy Participants |
Primary outcome
To examine the long-term pulmonary and nutritional effects of CFTR modulators.
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Rayment, MDCM principal investigator
University of British Columbia
Bradley Quon, MD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alam Lakhani (604-875-2345 ext. 7606, alam.lakhani@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the long-term pulmonary and nutritional effects of CFTR modulators. (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.