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CompletedNCT04448574Updated Dec 7, 2021

Chest Wall Deformities in Children - Epidemiological Data

An observational study in Chest Wall Deformity and Funnel Chest, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 2 sites in Germany. Open to participants aged 6 Years to 30 Years. Per ClinicalTrials.gov, last updated 2021-12-07.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

Study type
Observational
Model
Family-based
Time perspective
Retrospective
Enrollment
96
Ages
6 Years to 30 Years
Sex
All
01

Study summary

Pectus excavatum (PE) or funnel breast is the most common congenital deformity of the chest wall, which occurs in about 1 in 400 births with a boy to girl ratio of 4: 1 to 3: 1. The etiology of PE is largely undefined, but there are numerous indications that genetic factors play a role in the development of PE. Up to 40% of patients report affected family members with similar congenital deformities. In many families, PE follows a pattern that would be compatible with an autosomal dominant or recessive pattern of inheritance. The data on the frequent occurrence of PE in family members fluctuate greatly and only a few genes associated with a PE have been identified so far.

Read the detailed description

Previous studies suggest that sulfation of proteoglycans plays a crucial role in the normal development of cartilage and bone and could therefore be crucial in the genesis of the disease. The main catalytic machinery responsible for the biosynthesis and breakage of sulfate esters in the proteoglycans consists of various enzymes and transporters. Mutations in Sphingosine Kinase 1 (SK1) and Sphingosine Kinase 2 (SK2) genes that encode the transmembrane transporters of sulfate or enzymes that are involved in 3'-phosphoadenosine 5'-phosphosulfate (PAPS) synthesis have been identified as the cause of several inherited diseases that all have skeletal system deformities.

Connections between chest wall deformities with syndromes (e.g. Marfan, Noonan), anomalies (e.g. Poland, Moebius) or associations (e.g. Cantrell Pentalogy, PHACE) are well known. In contrast, there have so far been hardly any genetic studies of the isolated congenital chest wall deformities. Epidemiological data are insufficient and only a few groups deal with the inheritance and the incidence of this disease when it occurs in isolation.

02

Conditions studied

  • Chest Wall Deformity
  • Funnel Chest

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03

In context

Funnel Chest

79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.

This study's enrollment of 96 is above the median of 68 across 32 observational studies indexed under Funnel Chest.

Browse Funnel Chest studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who presented themselves in the study hospitals with the diagnosis of a chest wall deformity (funnel breast, keel breast, sternum cleft)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • . All patients who are in the Altona Children's Hospital or in the University Hospital Hamburg. Funnel breast, keel breast, sternal cleft
  • . A signed declaration of consent from the parents or legal guardians is available
  • . The patient has given a declaration of consent

Exclusion criteria

Exclusion Criteria:

  • Confirmation of another diagnosis associated with chest wall deformities:

    1. Marfan syndrome
    2. Noonan syndrome
    3. Poland syndrome
    4. Moebius syndrome
    5. Cantrell Pentalogy
    6. PHACE association
05

Study design

Observational model
Family-based
Time perspective
Retrospective
Enrollment
96 participants (actual)
Patient registry
No

Interventions

  • OtherChest Wall Deformities Questionaire

    Questionaire about epidemiological data was sent to Patients and families

06

What researchers measure

Primary outcomes

  1. familial accumulation of breast wall deformities Questionnaire

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Recording of clinical side effects on the familial accumulation of chest wall deformities

    Time frame: Through study completion, an average of 1 year

07

Study locations

2 sites
  • University Hospital Hamburg Eppendorf - Department of pediatric surgery
    Hamburg, 20246, Germany
  • The Altona Children's Hospital
    Hamburg, 22763, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2019 to primary completion in Jun 2020, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2020
First posted
Jun 26, 2020
StartActual
Sep 1, 2019
Primary completionActual
Jun 1, 2020
CompletionActual
Jun 1, 2020
Last update
Dec 7, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04448574
Responsible party
Dr. med. Julian Trah (Medical Doctor, Universitätsklinikum Hamburg-Eppendorf) — Principal investigator
First posted
Jun 26, 2020
Start date
Sep 1, 2019
Primary completion
Jun 1, 2020
Completion
Jun 1, 2020
Last update
Dec 7, 2021

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 Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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