Genetic Examination of Patients With Primary Multiple Hernia | NCT00979095

Studies
Genetic Examination of Patients With Primary Multiple Hernia

NCT00979095

Sponsor

Herlev Hospital

Status

Unknown status

Last Update Posted

Oct 13, 2010Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Multiple Hernia

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jun 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Sep 15, 2009

First Submission Date that Met QC Criteria

Sep 16, 2009

First Posted Date

Sep 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2010

Last Update Posted Date

Oct 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multiple hernia		Patients with more than 3 primary hernias
Control group		Patients without hernias

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic expression of relevant genes between the groups		12 months

Secondary Outcomes

Measure	Description	Time Frame
Amount of serological biomarkers (MMP's) correlated to gene expression		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with minimum 3 primary hernias

Exclusion Criteria:

Patients under 18 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Danish citizens. Data have been retracted from The Danish Hernia Database.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacob Rosenberg, Prof. MD	Herlev Hospital	Study Director
Jakob Burcharth, MD	Herlev Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jacob Rosenberg	Recruiting	Herlev Hospital	Herev	2730	Denmark