HerniaNCT00991484
Collagen Analysis and Genetic Analysis of Families With Tendency to Hernias
An observational study of Hernia, run by Herlev Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients in Denmark operated or diagnosed with hernias who are member of a family with tendency to hernias.
Who may be able to join
- adults over 18 years
- adults must be members of a family where there are presence of hernias in minimum generation.
Who cannot join
- infections
- pregnant
- mentally ill patients
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Herlev Hospital
Dk-2730, Herlev, Herlev, 2730
jakob Burcharth, MS, 004544884488, jakobburcharth@gmail.com
Jakob Burcharth, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Hernia
- Keywords
- ventral, inguinal, hernia, inheritance, genetics
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control group | Not described | |
| individuals from hernia-family | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of collagen-genes or other relevant genes by microarray analysis compared with presence of hernia
Measured: 1 year
Secondary outcomes (1)
Amount of collagen subtypes measured subcutaneously.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jacob Rosenberg, Prof. MD, Study director, Herlev HospitalJakob Burcharth, MD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991484
- Sponsor's protocol ID
- H-4-2009-123
- Status last verified
- Oct 2010
- First submitted
- 7 Oct 2009
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen-subtype Analysis in Subcutaneous Tissue and Genetic Analysis on Patients From Families With a Tendency to Hernias
- ClinicalTrials.gov ID
- NCT00991484
- Acronym / sponsor ID
- H-4-2009-123
- Conditions
- Hernia
- Keywords
- ventral, inguinal, hernia, inheritance, genetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | – |
| individuals from hernia-family | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients in Denmark operated or diagnosed with hernias who are member of a family with tendency to hernias.
Key inclusion criteria (2 listed)
- adults over 18 years
- adults must be members of a family where there are presence of hernias in minimum generation.
Key exclusion criteria (3 listed)
- infections
- pregnant
- mentally ill patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expression of collagen-genes or other relevant genes by microarray analysis compared with presence of hernia
Time frame: 1 year
1 secondary outcome
Amount of collagen subtypes measured subcutaneously.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Rosenberg, Prof. MD study director
Herlev Hospital
Jakob Burcharth, MD principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jakob Burcharth, MD (0045 44884488 ext. 89434, jakobburcharth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of collagen-genes or other relevant genes by microarray analysis compared with presence of hernia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.