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Collagen Analysis and Genetic Analysis of Families With Tendency to Hernias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00991484
Recruitment Status : Unknown
Verified October 2010 by Herlev Hospital.
Recruitment status was:  Recruiting
First Posted : October 8, 2009
Last Update Posted : October 13, 2010
Information provided by:
Herlev Hospital

Brief 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.

Condition or disease

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Collagen-subtype Analysis in Subcutaneous Tissue and Genetic Analysis on Patients From Families With a Tendency to Hernias
Study Start Date : December 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

control group
individuals from hernia-family

Primary Outcome Measures :
  1. Expression of collagen-genes or other relevant genes by microarray analysis compared with presence of hernia [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Amount of collagen subtypes measured subcutaneously. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
blood samples and subcutaneous tissue

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients in Denmark operated or diagnosed with hernias who are member of a family with tendency to hernias.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00991484

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Contact: Jakob Burcharth, MD 0045 44884488 ext 89434

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Herlev Hospital Recruiting
DK-2730, Herlev, Herlev, Denmark, 2730
Contact: jakob Burcharth, MS    004544884488   
Principal Investigator: Jakob Burcharth, MD         
Sponsors and Collaborators
Herlev Hospital
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Study Director: Jacob Rosenberg, Prof. MD Herlev Hospital
Principal Investigator: Jakob Burcharth, MD Herlev Hospital
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Responsible Party: Jakob Burcharth, MD., Herlev Hospital, Department of surgical Gastroenterology Identifier: NCT00991484    
Other Study ID Numbers: H-4-2009-123
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010
Keywords provided by Herlev Hospital:
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical