Ataxia TelangiectasiaNCT00951886
The Validity of Forced Expiratory Maneuvers in Ataxia Telangiectasia Studied Longitudinally
An observational study of Ataxia Telangiectasia, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 20 years
- Conditions the study is for
- Ataxia Telangiectasia
- How many people
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Patients with proven Ataxia Telangiectasia
Who cannot join
- inability to perform spirometry
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Pulmonary Unit, The Edmond and Lily Safra Children's Hospital Chaim Sheba Medical Center, Tel HaShomer
Ramat Gan, 52621
About this study
Official title: The Validity of Forced Expiratory Maneuvers in Ataxia Teleangiectasia Studied Longitudinally
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.
- Conditions
- Ataxia Telangiectasia
- Keywords
- Ataxia Teleangiectasia, Spirometry, Respiratory rare diseases
- Medical subject headings
- Ataxia Telangiectasia
What is being measured
The primary outcome is the main question the study is designed to answer.
spirometry measurements
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJul 2009
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxia TelangiectasiaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951886
- Sponsor's protocol ID
- SHEBA-08-5418-OE-CTIL
- Status last verified
- Aug 2009
- First submitted
- 2 Aug 2009
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of Forced Expiratory Maneuvers in Ataxia Teleangiectasia Studied Longitudinally
- ClinicalTrials.gov ID
- NCT00951886
- Acronym / sponsor ID
- SHEBA-08-5418-OE-CTIL
- Conditions
- Ataxia Telangiectasia
- Keywords
- Ataxia Teleangiectasia, Spirometry, Respiratory rare diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2009
- Study completion
- Jul 2009 (estimated)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Patients with proven Ataxia Telangiectasia
Key exclusion criteria (1 listed)
- inability to perform spirometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
spirometry measurements
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ataxia Telangiectasia, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spirometry measurements (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2009.