NCT05764980

Brief Summary

The rationale of the study is to analyze visual function and correlate them with adaptive functions in patients with CHARGE syndrome in order to identify a pattern of specific indicators to enable better patient care

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 1, 2023

Last Update Submit

March 1, 2023

Conditions

CHARGE Syndrome

Keywords

CHARGE syndromeVisual function

Outcome Measures

Primary Outcomes (1)

  • To demonstrate the correlation between severity of anatomical impairment and neurovisual ability.

    to detect aspects of visual function by studying ocular motility, visual acuity, contrast sensitivity, distance attention, and binocular visual field

    4 years

Interventions

visual function evaluationBEHAVIORAL

visual function evaluation

Eligibility Criteria

Age0 Years - 90 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of all ages with molecularly confirmed CHARGE sidnrome

You may qualify if:

  • Patients with molecularly confirmed CHARGE syndrome.

You may not qualify if:

  • Patients with CHARGE syndrome that has not been molecularly confirmed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli Irccs

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

CHARGE Syndrome

Condition Hierarchy (Ancestors)

Deaf-Blind DisordersDeafnessHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesBlindnessVision DisordersColobomaEye Diseases, HereditaryEye DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Giuseppe Zampino, medicine

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Zampino, medicine

CONTACT

00393392381870giuseppe.zampino@unicatt.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 13, 2023

Study Start

March 15, 2021

Primary Completion

March 15, 2023

Study Completion

January 1, 2024

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations

IT(1)