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Perceptions of the CF Screening Protocol Incorporating NGS

NCT06299566 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-03-08

No results posted yet for this study

Summary

Newborn bloodspot screening (from now on referred to as screening) for cystic fibrosis (CF) became part of the national screening programme in 2007. Screening for CF is also well established internationally. The current process works well but has some disadvantages: carrier reporting - which is not the intention of CF screening in the UK (\~200 pa); need for repeat samples which can be costly and contribute to parental worry (\~300 pa.); mutation panels not fully reflecting the ethnic diversity of the birth population; identification of children designated as CF screen positive, inconclusive diagnosis (CFSPID) which can cause uncertainty (\~20-30 pa).

A trial of NGS in one centre in the UK, for one year found that it was technically feasible at reasonable cost and with an acceptable turn around time. In addition, the trial determined that using NGS could mitigate against some of the disadvantages described above.

The purpose of this piece of work was to:

1. Gather, compare and analyse the views of a range of stakeholders on the proposed CF screening protocol incorporating NGS.
2. Use the outcomes to inform discussions and decisions by the fetal, maternal and child health (FMCH) group and UK National Screening Committee (NSC) about the proposed protocol
3. Consider what generalisable information on the views of stakeholders on newborn screening could be generated from this exercise to inform other FMCH and UK NSC discussions
4. Evaluate and learn from the exercise to inform future stakeholder engagement activities by the UK NSC and screening programmes.

Conditions

Sponsors & Collaborators

  • University of Warwick

    collaborator OTHER

  • Coventry University

    collaborator OTHER

  • Barts & The London NHS Trust

    collaborator OTHER

  • Cystic Fibrosis Trust

    collaborator OTHER

  • King's College London

    lead OTHER

Eligibility

Min Age
10 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • United Kingdom

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06299566 on ClinicalTrials.gov