Research with human participants

Overview of medical research in the Netherlands

Rare Facial Clefts: Physical and Psychological Outcome and it's Implications, addendum: "Fysical features of patients with proven genetic mutation (EfnB1) and clinical diagnosis of Craniofrontonasal Dysplasia"

Published:
Last updated:

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Other condition
Study type
Observational non invasive

ID

NL-OMON35214

Source

ToetsingOnline

Brief title

Rare Facial Clefts

Condition

  • Other condition
  • Congenital and hereditary disorders NEC
  • Head and neck therapeutic procedures

Synonym

Craniofrontonasal Clefts, Rare Facial Clefts

Health condition

Psychologische status

Research involving

Human

Sponsors and support

Primary sponsor :
Erasmus MC, Universitair Medisch Centrum Rotterdam
Source(s) of monetary or material Support :
Ministerie van OC&W,CZ groep Zorgverzekeringen,Stichting Achmea Gezondheidszorg,Stichting Achmea Gezondheidszorg;CZ Fonds

Intervention

Keyword :
Adults, Facial Cleft, Physical Outcome, Psychological Outcome

Outcome measures

Primary outcome

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Secondary outcome

N.V.T.

Background summary

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Study objective

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Study design

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Study burden and risks

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Public
Erasmus MC, Universitair Medisch Centrum Rotterdam

Dr. Molewaterplein 50
3015GE Rotterdam
NL
Scientific
Erasmus MC, Universitair Medisch Centrum Rotterdam

Dr. Molewaterplein 50
3015GE Rotterdam
NL

Listed location countries

Netherlands

Age

Adolescents (12-15 years)
Adolescents (16-17 years)
Adults (18-64 years)
Children (2-11 years)
Elderly (65 years and older)

Inclusion criteria

All patients with a proven genetic mutation on the EfnB1 gene, and treated in the Erasmus MC or Sophia's Hospital.

Exclusion criteria

All patients without a proven genetic mutation on the EfnB1 gene, and/ or never treated in the Erasmus MC or Sophia's Hospital.

Design

Study type :
Observational non invasive
Intervention model
:
Other
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Other

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
30
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL11643.078.06