NCT04331015

Brief Summary

To study the positive predictive value of Audiogene v.4.0 open source online machine learning tool in accurately predicting DFNA9 (DeaFNess autosomal dominant ninth) as top 3 gene loci in a large series of genetically confirmed c.151C\>T,p.Pro51Ser (p.P51S) variant carriers in COCH (coagulation factor C Homology).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

February 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

March 31, 2020

Last Update Submit

April 2, 2020

Conditions

Keywords

COCHDFNA9sensorineural hearing loss

Outcome Measures

Primary Outcomes (3)

  • hearing threshold

    audiometry (pure tone) decibel hearing level (dB HL) left, right ear , binaural average

    1 hour

  • age

    years, age at time of audiometry

    1 hour

  • prediction gene locus

    top 3 gene loci as predicted by Audiogene v4.0 machine learning tool

    1 hour

Interventions

Pure tone audiometryDIAGNOSTIC_TEST

pure tone audiometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A large cohort of 111 genetically confirmed p.P51S variant carriers, of whom audiometric data was collected from

You may qualify if:

  • at least 18 years
  • genetically confirmed c.151 C\>T, p.Pro51Ser variant carrier in COCH gene
  • not contra-indication for audiometric testing

You may not qualify if:

  • \<18 years
  • no carrier status for c.151C\>T, p.Pro51Ser
  • no auditory data available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

University of Antwerp

Antwerp, 2650, Belgium

Location

Related Publications (1)

  • Taylor KR, Deluca AP, Shearer AE, Hildebrand MS, Black-Ziegelbein EA, Anand VN, Sloan CM, Eppsteiner RW, Scheetz TE, Huygen PL, Smith RJ, Braun TA, Casavant TL. AudioGene: predicting hearing loss genotypes from phenotypes to guide genetic screening. Hum Mutat. 2013 Apr;34(4):539-45. doi: 10.1002/humu.22268. Epub 2013 Feb 19.

Related Links

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Audiometry, Pure-Tone

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AudiometryHearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Vincent Van Rompaey, MD,PhD

    University Hospital, Antwerp

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 2, 2020

Study Start

February 1, 2020

Primary Completion

March 28, 2020

Study Completion

March 28, 2020

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations