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Trial registered on ANZCTR

Registration number

ACTRN12626001279314

Ethics application status

Approved

Date submitted

14/09/2026

Date registered

26/10/2026

Date last updated

26/10/2026

Date data sharing statement initially provided

26/10/2026

Type of registration

Retrospectively registered

Titles & IDs

Public title

Outliving The CF Pamphlet: Investigating whether the bodies of adults living with cystic fibrosis are ageing faster than they should.

Scientific title

Outliving The CF Pamphlet: Assessing biological ageing in people living with Cystic Fibrosis to assess markers linked to age-related disease.

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

OTCFP (Outliving The CF Pamphlet)

Related trial records

Health condition

Health condition(s) studied:

Cystic fibrosis

Advanced biological ageing

Condition category

Condition code

Human Genetics and Inherited Disorders

Cystic fibrosis

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of the intervention or exposure

Participants with Cystic Fibrosis (CF) and control participants are both assessed once.
Upon consent and study entry, a single visit is scheduled.
During the 1 hour visit, the participant first completes a survey regarding family ethnic background, family disease history, their personal exercise and smoking history, and current physical and mental health status. Information is also collected from the participant regarding date of birth, sex at birth, and whether they are diagnosed with CF. Finally, blood is collected by venous phlebotomy.
There is no follow-up observation.

Intervention code [1]

Not applicable

Description of the comparator or control

Persons without cystic fibrosis or any other chronic respiratory disease and no smoking history, matched by sex and age to within 12 months either side of date of birth.

Control participants are assessed once.
Upon consent and study entry, a single visit is scheduled.
During the 1 hour visit, the control participant first completes a survey regarding family ethnic background, family disease history, their personal exercise and smoking history, and current physical and mental health status. Information is also collected from the control participant regarding date of birth, sex at birth, and confirming they have not been diagnosed with CF. Finally, blood is collected by venous phlebotomy.
There is no follow-up observation.

Control group

Active

Outcomes

Primary outcome [1]

Epigenetic age (GrimAge2) in adults with cystic fibrosis compared with age- and sex-matched controls

Timepoint [1]

Single timepoint at study entry

Primary outcome [2]

Proteomic age gap in adults with cystic fibrosis compared with age- and sex-matched controls.

Timepoint [2]

Single timepoint at study entry

Secondary outcome [1]

Epigenetic age (Horvath pan-tissue clock) in adults with cystic fibrosis compared with age- and sex-matched controls

Timepoint [1]

Single timepoint at study entry

Secondary outcome [2]

Epigenetic age (PhenoAge) in adults with cystic fibrosis compared with age- and sex-matched controls.

Timepoint [2]

Single timepoint at study entry

Secondary outcome [3]

Pace of biological ageing (DunedinPACE) in adults with cystic fibrosis compared with age- and sex-matched controls.

Timepoint [3]

Single timepoint at study entry

Secondary outcome [4]

Proportions of blood immune populations (neutrophils, CD4 T, CD8 T, B and NK cells, classical and non-classical monocytes, and dendritic cell subsets) in adults with CF compared with age- and sex-matched controls will be analysed as a composite secondary outcome.

Timepoint [4]

Single timepoint at study entry

Eligibility

Key inclusion criteria

Cystic Fibrosis cohort:
1. Diagnosis of Cystic Fibrosis

Control cohort:
1. Matched to a participant in the Cystic Fibrosis cohort for sex, within 12 months of date of birth

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

No

Key exclusion criteria

Cystic Fibrosis cohort:
1. Pregnancy

Control cohort:
1. Chronic respiratory disease
2. Former or current smokers, defined as smoking more than 100 cigarettes in their lifetime.
3. Pregnancy.

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Timing

Prospective

Statistical methods / analysis

The study sample size of a minimum 90 in each cohort was informed by the requirements of the primary outcomes.

Proteomics sample size was calculated using the Olink study size calculator and advice from product specialists. For a 2-group comparison (e.g. CF versus control) across the 5,416 proteins that can be detected in the assay, a minimum sample size of 86 was required in each cohort to detect a standard effect size (Cohen's d) of 0.42 at the Bonferroni-corrected significance level of 9.2e-06 (overall 0.05) and with a power of 80%.

The most pertinent study design in the literature to our outcome assessed blood epigenetic clocks in 15 people diagnosed with COPD and 27 healthy controls (Hernandez Cordero et al 2022, Biomedicines). Fifteen participants were sufficient to determine that the blood of COPD participants displayed a significantly older biological age (74 ±6 years) than their chronological age (70 ±8 years), that was not seen in the control cohort. As the COPD cohort had a much older chronological age than the WA adult CF population (34.9 years ±12 years), one risk with the younger age is that the increase in biological aging could be smaller than that reported by Hernandez Cordero et al. A minimum group size of 90 people with CF, dictated by the proteomics analysis, is sufficient for 86% power at a significance level of 0.05 in a one-way test of our hypothesis, biological age delta from chronological age is greater than 1 year, with the null hypothesis mean delta set to 0 and standard deviation set to 3.5.

Power calculations for the immunophenotyping assays were performed using the Sensei tool (Liang et al 2022, BMC Bioinformatics). The 90 samples would be at least 80% powered to detect between CF and control groups, a 2-fold difference in rare cell populations (e.g. 0.05% ±1% versus 1% ±1%), through to a 3.5% difference in abundant cell populations (e.g. 60% ±5% versus 62.1% ±5%), at a significance level of 0.05.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

13/08/2026

Date of last participant enrolment

Anticipated

30/06/2027

Actual

Date of last data collection

Anticipated

30/06/2027

Actual

Sample size

Target

90

Accrual to date

14

Final

Recruitment in Australia

Recruitment state(s)

WA

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Vertex Cystic Fibrosis Research Innovation Award

Address [1]

Country [1]

United States of America

Primary sponsor type

Charities/Societies/Foundations

Name

Institute for Respiratory Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

WA Health Central HREC

Ethics committee address [1]

https://www.health.wa.gov.au/Articles/U_Z/WA-Health-Central-HREC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/04/2026

Approval date [1]

30/06/2026

Ethics approval number [1]

RGS0000008458

Summary

Brief summary

We know that in the general population, aging is characterised by progressive biological changes (“biological aging”) that increase risks for infection, cardiovascular disease, or cancer, and consequently these increase the risk of death. People with CF have faced biological stresses from birth, due to multiple episodes of severe illness, altered diet, and heavy medication use, and we hypothesise that people with CF will show signs of accelerated biological aging.

The aim of the “Outliving the CF Pamphlet” study is to work in partnership with a study consumer reference group and answer whether accelerated biological aging is a factor in CF, and how this aligns with the community’s experiences and concerns.

This study will recruit participants from both the CF and general populations to donate blood.  Participant sex, age and family history of chronic disease will be recorded. Participants will be reimbursed for costs associated with the research visit. This blood will be deidentified and analysed in the laboratory of CPI Garratt as well as external partners for changes to DNA, blood proteins, and immune system that are known to relate to aging.

Trial website

https://www.resphealth.org.au/units/host-and-pathogen-biology-in-cystic-fibrosis/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Luke Garratt

Address

Institute for Respiratory Health, 6 Verdun St, Nedlands 6009, Western Australia

Country

Australia

Phone

+61 422 915 294

Fax

Email

[email protected]

Contact person for public queries

Name

Luke Garratt

Address

Institute for Respiratory Health, 6 Verdun St, Nedlands 6009, Western Australia

Country

Australia

Phone

+61 422 915 294

Fax

Email

[email protected]

Contact person for scientific queries

Name

Luke Garratt

Address

Institute for Respiratory Health, 6 Verdun St, Nedlands 6009, Western Australia

Country

Australia

Phone

+61 422 915 294

Fax

Email

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• All de-identified individual participant data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
At the end of the study
To:
A finite period of: 7 years

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?

Yes: Participant consent forms will specify whether data can be utilised in other studies and the specific conditions (research topic, location of work, commercial or non-commercial) under which this can occur.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.