The Validity of Forced Expiratory Maneuvers in Ataxia Tel... | NCT00951886

Studies
The Validity of Forced Expiratory Maneuvers in Ataxia Telangiectasia Studied Longitudinally

NCT00951886

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Aug 4, 2009Estimated

Enrollment

28Actual

Phase

Not provided

Conditions

Ataxia Telangiectasia

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 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Not provided

Completion Date

Jul 2009Estimated

First Submitted Date

Aug 2, 2009

First Submission Date that Met QC Criteria

Aug 3, 2009

First Posted Date

Aug 4, 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

Aug 3, 2009

Last Update Posted Date

Aug 4, 2009Estimated

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

Rationale: Forced spirometry maneuvers are not routinely performed in patients with Ataxia Telangiectasia (A-T), even though they suffer from respiratory illnesses.

Objectives: To study the feasibility and validity of forced spirometry in A-T patients.

Methods: Patients will perform spirometry during clinical visits. Parameters studied will be technical quality, relation to predicted values, age, pulmonary illness, body mass index, mutational status and mutation.

Detailed Description

Not provided

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

28Actual

Measure	Description	Time Frame
spirometry measurements		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with proven Ataxia Telangiectasia

Exclusion Criteria:

inability to perform spirometry

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Patients with Ataxia Telangiectasia who are followed and treated in the National A-T center at Safra Children's Hospital, Sheba Medical Center, Ramat-Gan, Israel

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Pulmonary Unit, The Edmond and Lily Safra Children's Hospital Chaim Sheba Medical Center, Tel HaShomer		Ramat Gan		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D001260	Ataxia Telangiectasia

Ancestor Terms

ID	Term
D020754	Spinocerebellar Ataxias
D002524	Cerebellar Ataxia
D002526	Cerebellar Diseases
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided