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Collagen Analysis and Genetic Analysis of Families With Tendency to Hernias
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Herlev Hospital.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Herlev Hospital
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00991484
First received: October 7, 2009
Last updated: October 12, 2010
Last verified: October 2010
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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 ]
Secondary Outcome Measures:
- Amount of collagen subtypes measured subcutaneously. [ Time Frame: 1 year ]
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 (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 Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00991484
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
| 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 |
Keywords provided by Herlev Hospital:
|
ventral inguinal hernia inheritance genetics |
Additional relevant MeSH terms:
|
Hernia Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on July 19, 2017