Collagen Analysis and Genetic Analysis of Families With Tendency to Hernias

Hernia Clinical Trial

Official title:

Collagen-subtype Analysis in Subcutaneous Tissue and Genetic Analysis on Patients From Families With a Tendency to Hernias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00991484
• Other study ID #: H-4-2009-123
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2009
• Last updated: October 12, 2010
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2010
• Source: Herlev Hospital
• Contact: Jakob Burcharth, MD
• Phone: 0045 44884488
• Email: jakobburcharth[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: Danish scientific and ethical committee of the Captital Region of Denmark
• Study type: Observational

Clinical Trial Summary

Analysis of collagen subtype subcutaneously and genetic analysis of patients from families with a tendency to hernias. Furthermore circulating biomarkers and biomarkers extracted from the subcutaneously tissue such as MMP's (matrix metallo proteinases) and TIMP's (tissue inhibitor of metallo proteinases) will be measured.

Description:

Research has shown relationship between hernias and collagen subtype I/III ratio, biomarkers such as MMP's TIMP's and other diseases such as Ehlers-Danlos, Marfans syndrome, AAA (abdominal aortic aneurysms), diverticulosis and rectal prolapse. Furthermore has research raised hypothesis about inheritance of hernias. The investigators are performing genetic examination combined with analysis of collagen and biomarkers on patients belonging to families with tendency to hernias.

Other examinations performed on the patients enrolled in this study:

• Ultrasound (US) examination of the abdominal aorta to discover possible abdominal aortic aneurysms.

• Beightons score to evaluate the degree of joint hypermobility.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults over 18 years

• adults must be members of a family where there are presence of hernias in minimum generation.

Exclusion Criteria:

• infections

• pregnant

• mentally ill patients

Study Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia

Locations

Country	Name	City	State
Denmark	Herlev Hospital	DK-2730, Herlev	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of collagen-genes or other relevant genes by microarray analysis compared with presence of hernia		1 year	Yes
Secondary	Amount of collagen subtypes measured subcutaneously.		1 year	Yes