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:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT06299566
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged over 18 years of age who:
(i) Were diagnosed with CF in childhood (ii) Were diagnosed with CF as adults (including those who would have been identified as CFSPID if NBS had been available and reporting it) (iii) Are carriers of CF (including parents/relatives of children/adults with CF and adults identified via other routes e.g. private testing)
2. Parents (aged over 18 years) of children identified through NBS who:
(iv) Have CF (v) Are carriers of CF (vi) Have a CFSPID designation (vii) Have received a false positive NBS result for CF (viii) Have received a false negative NBS result for CF
3. Children aged over 10 years of age\* who:
(ix) Have CF (x) Have a CFSPID designation (xi) Are carriers of CF and have been informed of their carrier status
\*Ten years of age has been chosen for both pragmatic reasons and because this represents the age at which children will begin preparing for transition to adult services and therefore a period of increased independence and/or preparing for specialist review
4. Professionals involved in processing and/or communicating positive NBS results for CF to families or supporting families in health, community or education settings e.g. doctors, nurses, geneticists, genetic counsellors, midwives, social workers, dieticians, physiotherapists, teachers, university lecturers, charities.
Exclusion Criteria:
Exclusion criteria for those affected by CF:
1. Adults or children with non CF related co-morbidities that are likely to influence their perception of the proposed CF screening protocol incorporating NGS
2. Parents whose child has died prior to being approached to be involved in the study
3. Adults or children unable to understand the PIS and give informed consent/assent respectively
4. Adults or children whose recruitment is contraindicated on psychosocial or medical grounds (identified by their health visitor or specialist team).
Exclusion criteria for professionals:
Those not involved in processing, communicating positive NBS results for CF to families or supporting families in health, community or education settings.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
99 Years
Study:
NCT06299566
Study Brief:
Protocol Section:
NCT06299566