Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07402434
Eligibility Criteria:
Inclusion Criteria:
Group A: Difficult Cystic Fibrosis Diagnosis Cohort
Inclusion criteria:
1. Patients with difficult-to-diagnose CF\*
2. Adults (≥16y)
3. Willing to undergo rectal biopsy
4. Able to comply with the study
* Definition: Non-diagnostic first line CFTR testing (individuals who do not fulfil CF diagnostic criteria \[2 CF-causing CFTR variants and/or sweat chloride concentration ≥60 mmol/L\]). Of note, there are some individuals with \<2 CF-causing CFTR variants after extended CFTR genetic analysis but with a SCC \>60mmol/L. Expansion of the patient pool to include these is permissible.
Group B: Cystic Fibrosis Patient Cohort
Inclusion criteria:
1. Patients with confirmed Cystic Fibrosis
2. Adults (≥16y)
3. Willing to undergo rectal biopsy for this study
4. Able to comply with the study
Group C: Non-Cystic Fibrosis Patient Cohort
Inclusion criteria:
1. Patients without Cystic Fibrosis or CFTR-related disorder
2. Adults (≥16y)
3. Willing to undergo rectal biopsy for this study (if undergoing a lower GI endoscopy for other purposes)
4. Able to comply with the study
Exclusion Criteria:
Group A: Difficult Cystic Fibrosis Diagnosis Cohort
Exclusion criteria:
1. Contra-indication to rectal biopsy (e.g. significant bleeding diathesis)
2. History of lung transplantation
3. Receiving CFTR modulator treatment
4. Current participation (or participation within one month of enrolment) in a clinical trial of an investigational medicinal product which affects CFTR function (e.g. CFTR modulators, genetic therapies)
5. Female who is pregnant or breastfeeding
6. Unable to provide informed consent
Group B: Cystic Fibrosis Patient Cohort
Exclusion criteria:
1. Contra-indication to rectal biopsy (e.g. significant bleeding diathesis)
2. Current participation (or participation within one month of enrolment) in a clinical trial of an investigational medicinal product which affects CFTR function (e.g. CFTR modulators, genetic therapies)
3. Female who is pregnant or breastfeeding
4. Unable to provide informed consent
5. Exclude all subjects where diagnosis of CF is in doubt
Group C: Non-Cystic Fibrosis Patient Cohort
Exclusion criteria:
1. Contra-indication to rectal biopsy (e.g. significant bleeding diathesis)
2. Female who is pregnant or breastfeeding
3. Unable to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT07402434
Study Brief:
Protocol Section:
NCT07402434