Search for Genetic Basis of Vulvodynia | NCT01664962

Studies
Search for Genetic Basis of Vulvodynia

NCT01664962

Sponsor

Western Galilee Hospital-Nahariya

Status

Completed

Last Update Posted

Aug 14, 2012Estimated

Enrollment

168Actual

Phase

Not provided

Conditions

Vulvodynia

Interventions

Not provided

Countries

Israel

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

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jan 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Aug 9, 2012

First Submission Date that Met QC Criteria

Aug 13, 2012

First Posted Date

Aug 14, 2012Estimated

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

Aug 13, 2012

Last Update Posted Date

Aug 14, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Jacob Bornstein, Principal Investigator, Western Galilee Hospital-NahariyaPrincipal Investigator

Lead Sponsor

Western Galilee Hospital-NahariyaOTHER_GOV

Collaborators

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Detailed Description

The short-term goal proposed for the current study was to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Eight polymorphic SNPs in the three different genes suspected to be involved in LPV has been examined as follow:

HSPE gene: Four polymorphic SNPs: rs4693608, rs11099592, rs6856901 and rs4364254 that were found to be informative in the Ashkenazi Jewish population
TRPV1 gene: Two polymorphic SNPs: rs222747 and rs8065080.
NGF gene: A novel T to C SNP in the promoter region at position -198 (rs11102930) and rs6330 which was found to be associated with anxiety-related personality traits and has been suggested to may affect intracellular processing and secretion of NGF.

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

168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Women with severe Vulvodynia
Healthy controls		Women without vulvodynia

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic association of Vulvodynia	the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).	four years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:o meeting Friedrich's criteria [50] for vulva vestibulitis syndrome

diagnosed by a gynecological examination with LPV
diagnosed with a severe degree of the syndrome according to Marinoff [48]
classified with the primary type of the syndrome according to an interview
with both parents of Ashkenazi origin.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Vulvodynia, Normal healthy controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Galilee Hospital		Nahariya			Israel

Condition Browse Module

MeSH Terms

ID	Term
D056650	Vulvodynia

Ancestor Terms

ID	Term
D014845	Vulvar Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

Not provided