NCT00951886

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

First QC Date

August 2, 2009

Last Update Submit

August 3, 2009

Conditions

Ataxia Telangiectasia

Keywords

Ataxia TeleangiectasiaSpirometryRespiratory rare diseases

Outcome Measures

Primary Outcomes (1)

  • spirometry measurements

    3 years

Eligibility Criteria

Age3 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patients with proven Ataxia Telangiectasia

You may not qualify if:

  • inability to perform spirometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Pulmonary Unit, The Edmond and Lily Safra Children's Hospital Chaim Sheba Medical Center, Tel HaShomer

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Ataxia Telangiectasia

Condition Hierarchy (Ancestors)

Spinocerebellar AtaxiasCerebellar AtaxiaCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocutaneous SyndromesAtaxiaDyskinesiasNeurologic ManifestationsTelangiectasisVascular DiseasesCardiovascular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPrimary Immunodeficiency DiseasesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 2, 2009

First Posted

August 4, 2009

Study Start

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

IL(1)