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Collagen Analysis and Genetic Analysis of Families With Tendency to Hernias

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Herlev Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00991484
First received: October 7, 2009
Last updated: October 12, 2010
Last verified: October 2010

October 7, 2009
October 12, 2010
December 2009
December 2010   (final data collection date for primary outcome measure)
Expression of collagen-genes or other relevant genes by microarray analysis compared with presence of hernia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00991484 on ClinicalTrials.gov Archive Site
Amount of collagen subtypes measured subcutaneously. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Collagen Analysis and Genetic Analysis of Families With Tendency to Hernias
Collagen-subtype Analysis in Subcutaneous Tissue and Genetic Analysis on Patients From Families With a Tendency to Hernias

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.

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.
Observational
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood samples and subcutaneous tissue

Non-Probability Sample

patients in Denmark operated or diagnosed with hernias who are member of a family with tendency to hernias.

Hernia
Not Provided
  • control group
  • individuals from hernia-family
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Jakob Burcharth, MD 0045 44884488 ext 89434 jakobburcharth@gmail.com
Denmark
 
NCT00991484
H-4-2009-123
No
Jakob Burcharth, MD., Herlev Hospital, Department of surgical Gastroenterology
Herlev Hospital
Not Provided
Study Director: Jacob Rosenberg, Prof. MD Herlev Hospital
Principal Investigator: Jakob Burcharth, MD Herlev Hospital
Herlev Hospital
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP