CClinicalTrials.gg
CompletedNCT04495218DIAUpdated Sep 19, 2024

NGS Panel of Incomplete Forms of Ocular Albinism

An observational study in Albinism, Ocular, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
53
Ages
0 Years and older
Sex
All
01

Study summary

Implementation of a next-generation sequencing panel of genes to identify deleterious variants in patients with incomplete forms of albinism.

Read the detailed description

Scientific context : Albinism is clinically characterised by cutaneous hypopigmentation and ophthalmologic features. These features common to all forms of albinism are foveal hypoplasia, misrouting of the optic nerves at the chiasm, retinal hypopigmentation, translucent irides and nystagmus. The molecular genetic lab at Bordeaux University Hospital is the national reference for the study of this disease. More than 1400 patients have been analyzed with a strategy including next-generation sequencing of the 19 known genes of albinism and array-CGH. Despite this thorough analysis, 25% of patients remain without molecular diagnosis. Our experience tells us that these patients often show an incomplete form of albinism with the presence of only few ophthalmologic signs. The molecular diagnosis is very challenging as the phenotype often overlaps with other ophthalmologic disorders.

02

Conditions studied

  • Albinism, Ocular

Browse trials for

Keywords

  • Next generation sequencing
  • Albinism
03

Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with a clinical diagnosis of incomplete form of albinism with presence of at least 2 signs of ocular albinism among which nystagmus, low vision, foveal hypoplasia, retinal hypopigmentation, translucent irides, misrouting of the optic nerves at the chiasm and having a specialized consultation in CHU de Bordeaux

Inclusion criteria

  • Minor and adult patient.
  • Patient presenting a clinical diagnosis of incomplete form of albinism with presence of at least 2 signs of ocular albinism among which nystagmus, low vision, foveal hypoplasia, retinal hypopigmentation, translucent irides, misrouting of the optic nerves at the chiasm.
  • Registered for the social security system.
  • Informed consent signed by patient or parent of a minor patient.

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate in research protocol.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
53 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patient with a diagnosis of incomplete form of albinism

    Biological: Blood samples

Interventions

  • BiologicalBlood samples

    Performed a 10 ml blood sample (2 unnamed samples of 5ml) in each of the 100 patients included.

05

What researchers measure

Primary outcomes

  1. Percentage of patients for whom a molecular diagnosis is obtained based on the panel of targeted genes

    the prevalence of finding at least two pathogenic variants is 10%.

    Time frame: Enrollment

06

Study locations

1 site
  • Centre Hospitalier Universitaire de Bordeaux
    Bordeaux, France
07

Registry details

Key details

Study ID
NCT04495218
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Jul 31, 2020
Start date
Nov 23, 2020
Primary completion
Feb 28, 2024
Completion
Feb 28, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion