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Collagen Analysis and Genetic Analysis of Families With Tendency to Hernias

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Herlev Hospital

Study Description
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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
Hernia

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.

Study Design
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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

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
control group
individuals from hernia-family


Outcome Measures
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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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00991484


Contacts
Contact: Jakob Burcharth, MD 0045 44884488 ext 89434 jakobburcharth@gmail.com

Locations
Denmark
Herlev Hospital Recruiting
DK-2730, Herlev, Herlev, Denmark, 2730
Contact: jakob Burcharth, MS    004544884488    jakobburcharth@gmail.com   
Principal Investigator: Jakob Burcharth, MD         
Sponsors and Collaborators
Herlev Hospital
Investigators
Study Director: Jacob Rosenberg, Prof. MD Herlev Hospital
Principal Investigator: Jakob Burcharth, MD Herlev Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jakob Burcharth, MD., Herlev Hospital, Department of surgical Gastroenterology
ClinicalTrials.gov Identifier: NCT00991484     History of Changes
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:
ventral
inguinal
hernia
inheritance
genetics

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical