Multiple HerniaNCT00979095
Genetic Examination of Patients With Primary Multiple Hernia
An observational study of Multiple Hernia, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The investigators are performing a genetic study of patients with multiple hernias (at least 3 primary hernias) versus a healthy control group. This genetic information is compared with circulating and subcutaneously biomarkers such as matrix-metalloproteinases (MMP's). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Hernia
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to Dec 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: Danish citizens. Data have been retracted from The Danish Hernia Database.
Who may be able to join
- Patients with minimum 3 primary hernias
Who cannot join
- Patients under 18 years
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Jacob Rosenberg
Herlev Hospital, Herev, 2730
Jakob Burcharth, MD, 44884488 ext. 89434, jakobburcharth@gmail.com
Jakob Burcharth, MD
About this study
Official title: Genetic Differences Between Patients With Multiple Hernia and a Healthy Control Group
The investigators are performing a genetic study of patients with multiple hernias (at least 3 primary hernias) versus a healthy control group. This genetic information is compared with circulating and subcutaneously biomarkers such as matrix-metalloproteinases (MMP's).
The hypothesis is that patients with multiple hernias have different expression of specific genes compared to the healthy control group.
Read the detailed description
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
- Multiple Hernia
- Keywords
- multiple 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 |
|---|---|---|
| Multiple hernia | Patients with more than 3 primary hernias | |
| Control group | Patients without hernias |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic expression of relevant genes between the groups
Measured: 12 months
Secondary outcomes (1)
Amount of serological biomarkers (MMP's) correlated to gene expression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple 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
- Case-control
- 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
- NCT00979095
- Sponsor's protocol ID
- H-D-2008-126
- Status last verified
- Oct 2010
- First submitted
- 15 Sep 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
- Genetic Differences Between Patients With Multiple Hernia and a Healthy Control Group
- ClinicalTrials.gov ID
- NCT00979095
- Acronym / sponsor ID
- H-D-2008-126
- Conditions
- Multiple Hernia
- Keywords
- multiple hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 17 Sep 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.
The investigators are performing a genetic study of patients with multiple hernias (at least 3 primary hernias) versus a healthy control group. This genetic information is compared with circulating and subcutaneously biomarkers such as matrix-metalloproteinases (MMP's).
The hypothesis is that patients with multiple hernias have different expression of specific genes compared to the healthy control group.
Detailed description
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
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple hernia | – | –Patients with more than 3 primary hernias |
| Control group | – | –Patients without hernias |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Danish citizens. Data have been retracted from The Danish Hernia Database.
Key inclusion criteria (1 listed)
- Patients with minimum 3 primary hernias
Key exclusion criteria (1 listed)
- Patients under 18 years
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
Genetic expression of relevant genes between the groups
Time frame: 12 months
1 secondary outcome
Amount of serological biomarkers (MMP's) correlated to gene expression
Time frame: 12 months
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 Multiple 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 1 inclusion and 1 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic expression of relevant genes between the groups (time frame: 12 months). 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.