Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-11-02

Brief Summary

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Assessment of the outcome of patients not concluded fir cystic fibrosis, either symptomatic patients or asymptomatic children detected by newborn screening for cystic fibrosis. The aim is to identify patients potentially at risk of progressing to the clinical spectrum of cystic fibrosis

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Detailed Description

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Among patients not concluded for the diagnosis of cystic fibrosis, some are carriers of CFTR-RD mutations, therefore at risk of progressing to a symptomatic form, and may already have a subclinical involvement that it is important to identify. Among patients who do not carry the CFTR-RD genotype, other patients may be at risk of developing symptoms, if they are carriers of an undetected variant or wrongly classified as non-pathogenic. It is important to detect them to prevent the onset of symptoms

Conditions

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CFTR-RD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with unconcluded diagnosis for cystic fibrosis

1. symptomatic patientscarrying 2 variants of CFTR, including at least 1 non CF causing
2. patients not concluded at neonatal screening of Cystic Fibrosis

data collection

Intervention Type OTHER

collection of data of generated by "real world" follow up

Interventions

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data collection

collection of data of generated by "real world" follow up

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

patients not concluded for the diagnosis of Cystic fibrosis either because of intermediate sweat test or because extensive genetic study has identified 2 vrainats at least 1 being not CF causing

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