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
  Purpose

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
Hernia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Amount of collagen subtypes measured subcutaneously. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

blood samples and subcutaneous tissue


Estimated Enrollment: 60
Study Start Date: December 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
control group
individuals from hernia-family

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 7, 2009
Last Updated: October 12, 2010
Health Authority: Denmark: Danish scientific and ethical committee of the Captital Region of Denmark

Keywords provided by Herlev Hospital:
ventral
inguinal
hernia
inheritance
genetics

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014