Actively Recruiting

All Genders
NCT05448326

The Diagnostic Observatory: Combating Diagnostic Wandering and Impasse Within the AnDDI-Rares Network

Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-11-26

1280

Participants Needed

1

Research Sites

361 weeks

Total Duration

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AI-Summary

What this Trial Is About

The Direction Générale de l'Organisation des Soins (DGOS) and the Banque Nationale de Données Maladies Rares (BNDMR) have launched a call for a letter of commitment for the implementation of a diagnostic observatory in order to fight against diagnostic wandering and impasse. In this context, the AnDDI-Rares network proposes 3 work packages (WP) to respond to the missions entrusted to it. Work package 1 of the diagnostic observatory includes a retrospective and prospective study to evaluate how diagnostic wandering and impasse has evolved within the network, with regard to the integration of new technologies, and the expectations of patients and their families. Work package 2 of the diagnostic observatory includes a reassessment of sporadic copy number variations (CNV) of unknown significance of more than 1 Mb obtained since the beginning of CGH array analyses in the territory. Work package 3 of the diagnostic observatory aims to help put an end to diagnostic wandering for patients with certain emblematic syndromes by proposing genome and RNA analysis, which provides a certain diagnosis and negative targeted molecular study.

CONDITIONS

Official Title

The Diagnostic Observatory: Combating Diagnostic Wandering and Impasse Within the AnDDI-Rares Network

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children or adults without a diagnosis after evaluation for developmental abnormalities including malformations, facial dysmorphia, learning or intellectual disabilities
  • Patients agreeing to new diagnostic testing including blood samples for genome sequencing
  • Affiliation to national health insurance or equivalent
  • Patients with developmental anomalies and a de novo CNV over 1 Mb of unknown or benign significance detected by CGH array
  • Patients and parents agreeing to resume diagnostic testing after CNV reanalysis
  • Patients with clinical diagnosis of Noonan, CHARGE, Kabuki, Cornelia de Lange, or Rubinstein-Taybi syndromes with negative molecular diagnosis
  • Parents able to consent and understand study procedures
  • Signed informed consent from biological parents and/or patient if adult
Not Eligible

You will not qualify if you...

  • Patients without developmental abnormalities
  • Patients with known diagnosis at time of past consultations
  • Patients unlikely to have the clinical diagnosis under study
  • Families unwilling to pursue molecular investigations
  • Patients previously investigated through another research project
  • Parents under court protection
  • Families where both parental authority holders are not biological parents

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Chu Dijon Bourogne

Dijon, France, 21000

Actively Recruiting

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Research Team

L

Laurence OLIVIER-FAIVRE

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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