Cluster Headache and SPINK-1 Gene | NCT02585739

Studies
Cluster Headache and SPINK-1 Gene

NCT02585739

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Oct 23, 2015Estimated

Enrollment

42Actual

Phase

Not Applicable

Conditions

Episodic or Chronic Cluster Headache

Interventions

blood sample

Countries

France

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

ID	Type	Description	Link
RC12_3011	Other Identifier	APHM

Status Module

Record Verification Date

Oct 2015

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

Oct 2011

Primary Completion Date

Nov 2013Actual

Completion Date

Jul 2015Actual

First Submitted Date

Oct 22, 2015

First Submission Date that Met QC Criteria

Oct 22, 2015

First Posted Date

Oct 23, 2015Estimated

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 22, 2015

Last Update Posted Date

Oct 23, 2015Estimated

Description Module

Brief Summary

Cluster headache (CH) is a rare, excruciating primary headache disorder. A genetic basis has been suggested by family and twin studies, but the mode of transmission seems to vary and the amount of heritability is unclear.

The number of genetic association studies investigating variants implicated in the pathophysiology of CH is limited. The HCRTR2 1246G > A and the ADH4 925A > G polymorphisms have been associated with CH. The former has been confirmed and may affect the hypothalamic hypocretin system. The aim of the present study was to investigate the possible link between SPINK 1 gene and cluster headache.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient	Experimental	patient with Cluster headache	Genetic: blood sample
healthy subject	Other	patient without Cluster headache	Genetic: blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sample	Genetic		healthy subject patient

Measure	Description	Time Frame
SPINK1 genotyping		2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People aged 18 or over
Patient consulting in Marseille's or Nice's Pain departments
Patient agreeing to participate to the research study
Patient with health insurance

Exclusion Criteria:

People aged under 18
Patient refusing to participate to the research study
Patient with deprivation of liberty

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
urielle desalbres	APHM	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012008	Recurrence
D003027	Cluster Headache

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D051303	Trigeminal Autonomic Cephalalgias

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided