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Collagen Analysis and Genetic Analysis of Families With Tendency to Hernias

Sponsor
Herlev Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00991484
Collaborator
(none)
60
Enrollment
1
Location
18
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated 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 :
    Dec 1, 2009
    Anticipated Primary Completion Date :
    Dec 1, 2010
    Anticipated Study Completion Date :
    Jun 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    control group
    individuals from hernia-family

    Outcome Measures

    Primary Outcome Measures

    1. Expression of collagen-genes or other relevant genes by microarray analysis compared with presence of hernia [1 year]

    Secondary Outcome Measures

    1. Amount of collagen subtypes measured subcutaneously. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Herlev Hospital DK-2730, Herlev Herlev Denmark 2730

    Sponsors and Collaborators

    • Herlev Hospital

    Investigators

    • Study Director: Jacob Rosenberg, Prof. MD, Herlev Hospital
    • Principal Investigator: Jakob Burcharth, MD, Herlev Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00991484
    Other Study ID Numbers:
    • H-4-2009-123
    First Posted:
    Oct 8, 2009
    Last Update Posted:
    Oct 13, 2010
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    ventral
    inguinal
    hernia
    inheritance
    genetics
    Additional relevant MeSH terms:
    Hernia

    Study Results

    No Results Posted as of Oct 13, 2010