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Clinical Trials in France / NCT07704281
Starting soon Observational

Follow-up of the Cohort of Newborns Screened at Birth Using TREC Analysis

NCT07704281 · tracked via the Priya Life Science France tracker
Sponsor
Nantes University Hospital
Phase
Observational
Started
2026-11-01
Last updated
2026-07-15

Condition(s) studied

Severe Combined Immunodeficiencies (SCID)

Investigational drug(s) / intervention(s)

Data collection

Data collection: The categories of data processed in the study database will be: * Clinical data * Laboratory data * Data related to newborn screening * Genetic data (only the results of genetic testing) * Care-related data (referral center, dates of tests, etc.)

Study summary

Since September 2025, neonatal screening for severe combined immunodeficiency (SCID) has been generalized in France. These genetic disorders, which are asymptomatic at birth, cause severe immunodeficiency, exposing infants to serious infections (viral, bacterial, or fungal) as early as the first year of life. Without early treatment and management, infectious complications can be life-threatening.

Studies show that this screening improves survival and quality of life and reduces treatment costs by enabling intervention before complications arise.

In France, the Ministry of Health referred this matter to the Haute Autorité de Santé (HAS), which issued a favorable opinion in January 2022 via a ministerial decree (published on April 16, 2025) regarding the combined screening for DICS and spinal muscular atrophy. These authorizations follow the DEPISTREC study (2015-2017), which demonstrated the effectiveness of this screening: 190,517 children were screened, resulting in a reduction in DICS-related deaths.

The primary objective of the study will be to describe the underlying causes of T-cell lymphopenia identified in newborns through neonatal screening by quantifying TRECs on Guthrie cards. (SCID; variant SCID; syndromic T-cell deficiency; secondary T-cell deficiency; attenuated SCID; Omenn syndrome; immunosuppressive treatment in the mother; not found; isolated prematurity).

Eligibility

Sex
ALL
Min age
—
Max age
5 Years
Healthy volunteers
No
Inclusion Criteria: * Children with a positive Guthrie test result, confirmed by lymphocyte immunophenotyping performed during their first visit with a pediatric specialist. Exclusion Criteria: * Children whose parents objected to the collection of data after receiving the informational letter

Primary outcome measure(s)

  • Etiology of T-cell lymphopenia identified through newborn screening using TREC quantification on Guthrie cards — Enrollment

Trial sites (1)

FacilityCityRegionStatus
Nantes university hospital Nantes France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07704281 on ClinicalTrials.gov ↗ ← All trials in France