Pathological ProcessesNCT00527670
Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias
An observational study of Pathological Processes, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The aim of this study is to compare collagen composition in the skin and fascia of patients with recurrent or incisional hernias versus normal controls. We will identify potential genes responsible for genetic alterations in collagen deposition by using gene chip analysis of the tissue obtained and comparing the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pathological Processes
- What is being tested?
- Recurrent Hernia
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Nov 2010
- 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: Surgical patients at the University of Missouri Healthcare system.
Who may be able to join
- Hernia Group: Diagnosis of ventral or incisional hernia.
- Control Group: appendicitis, symptomatic cholelithiasis or cholecystitis, adrenal disease necessitating adrenalectomy.
- Scheduled for an appropriate laparoscopic repair of above diagnosis.
- Females only: Not pregnant.
Who cannot join
- Steroid use
- Severe COPD or pulmonary disorders
- History of a connective tissue disorder
- Presentation for surgery with a diagnosis other than those listed above in inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Hospital and Clinics
Columbia, Missouri, 65212
About this study
The aim of this study is to compare collagen composition in the skin and fascia of patients with recurrent or incisional hernias versus normal controls. We will identify potential genes responsible for genetic alterations in collagen deposition by using gene chip analysis of the tissue obtained and comparing the hernia group versus controls. The ultimate goal of this study is to identify target genes which may help us eventually predict which patients are at risk for developing post-operative hernias.
Read the detailed description
This is a prospective, case control pilot study with the aim of identifying potential genetic influences on recurrent hernia formation. Patients with recurrent abdominal hernias will be compared with normal control subjects. The study endpoints will compare tissue collagen I/III ratios between the groups. It will also use gene chip technology to identify potential differences in gene expression between the two groups, followed by confirmation of the differential expression using RT-PCR.
Patients will be enrolled from the surgical clinic population. If they consent to the study, both the hernia group and the control group will have 0.5 x 0.5 x 0.1 cm3 pieces of skin and fascia collected at the time of their surgery. A small piece of tissue will be used for immunofluorescene to study collagen I/III ratios. RNA will be extracted from the rest of the tissue for the genetic studies.
- Conditions
- Pathological Processes
- Being tested
- Normal Controls, Recurrent Hernia
- Keywords
- Genomics
- Medical subject headings
- Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal ControlsProcedure or surgery
The control group will have small slivers of tissue removed from the skin and abdomen during surgery to compare genomic information.
Recurrent HerniaProcedure or surgery
This group will have small slivers of tissue removed from the skin and abdomen during hernia repair surgery to find genetic proof of hernias being inherited.
| Study group | Role | What they receive |
|---|---|---|
| Normal Controls | Healthy patients undergoing laparoscopic surgery for cholelithiasis, appendicitis, and adrenalectomy. Receives: Procedure: Normal Controls | |
| Recurrent Hernia | Patients presenting for laparoscopic repair of ventral or incisional hernias. Receives: Procedure: Recurrent Hernia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological ProcessesStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce Ramshaw, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527670
- Sponsor's protocol ID
- MO-1057938
- Status last verified
- Aug 2016
- First submitted
- 7 Sep 2007
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias
- ClinicalTrials.gov ID
- NCT00527670
- Acronym / sponsor ID
- MO-1057938
- Conditions
- Pathological Processes
- Keywords
- Genomics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Sep 2007 (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 aim of this study is to compare collagen composition in the skin and fascia of patients with recurrent or incisional hernias versus normal controls. We will identify potential genes responsible for genetic alterations in collagen deposition by using gene chip analysis of the tissue obtained and comparing the hernia group versus controls. The ultimate goal of this study is to identify target genes which may help us eventually predict which patients are at risk for developing post-operative hernias.
Detailed description
This is a prospective, case control pilot study with the aim of identifying potential genetic influences on recurrent hernia formation. Patients with recurrent abdominal hernias will be compared with normal control subjects. The study endpoints will compare tissue collagen I/III ratios between the groups. It will also use gene chip technology to identify potential differences in gene expression between the two groups, followed by confirmation of the differential expression using RT-PCR.
Patients will be enrolled from the surgical clinic population. If they consent to the study, both the hernia group and the control group will have 0.5 x 0.5 x 0.1 cm3 pieces of skin and fascia collected at the time of their surgery. A small piece of tissue will be used for immunofluorescene to study collagen I/III ratios. RNA will be extracted from the rest of the tissue for the genetic studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Controls | – | Procedure: Normal ControlsHealthy patients undergoing laparoscopic surgery for cholelithiasis, appendicitis, and adrenalectomy. |
| Recurrent Hernia | – | Procedure: Recurrent HerniaPatients presenting for laparoscopic repair of ventral or incisional hernias. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients at the University of Missouri Healthcare system.
Key inclusion criteria (4 listed)
- Hernia Group: Diagnosis of ventral or incisional hernia.
- Control Group: appendicitis, symptomatic cholelithiasis or cholecystitis, adrenal disease necessitating adrenalectomy.
- Scheduled for an appropriate laparoscopic repair of above diagnosis.
- Females only: Not pregnant.
Key exclusion criteria (4 listed)
- Steroid use
- Severe COPD or pulmonary disorders
- History of a connective tissue disorder
- Presentation for surgery with a diagnosis other than those listed above in inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal ControlsThe control group will have small slivers of tissue removed from the skin and abdomen during surgery to compare genomic information. | Procedure or surgery | Normal Controls |
| Recurrent HerniaThis group will have small slivers of tissue removed from the skin and abdomen during hernia repair surgery to find genetic proof of hernias being inherited. | Procedure or surgery | Recurrent Hernia |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Bruce Ramshaw, MD principal investigator
University of Missouri-Columbia
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 Pathological Processes, run by University of Missouri-Columbia at 1 site in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Aug 2016. 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 United States. 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?
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 8 Aug 2016.