Temporal ArteritisNCT01130857
Diagnostic Study of Temporal Arteritis
An observational study of Temporal Arteritis, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Despite a large and growing body of knowledge concerning the diagnosis of temporal arteritis, this potentially crippling disease still requires pathological diagnosis in practically every case. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temporal Arteritis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jul 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients suspected of temporal arteritis and referred to temporal artery biopsy
Who may be able to join
- Patients suspected of temporal arteritis and referred by their physicians to biopsy of a temporal artery.
Who cannot join
- Pregnancy; age > 80 or < 18; unable to answer study questions
Trial locations and contacts
No sites are listed yet.
Ioni Tsechori, MD contact
About this study
Official title: Diagnostic Tools in Temporal Arteritis - Towards the Development of a Diagnostic Algorithm
Despite a large and growing body of knowledge concerning the diagnosis of temporal arteritis, this potentially crippling disease still requires pathological diagnosis in practically every case. It seems likely that a correctly estimated clinical probability could help in evaluating imaging results in a way that might safely obviate temporal biopsy in a large segment of suspect cases.
With this aim in view, we intend to identify useful clinical items and integrate them in an appropriate diagnostic pathway.
- Conditions
- Temporal Arteritis
- Medical subject headings
- Giant Cell Arteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent decrease in future biopsy use.
Measured: 2 years
Secondary outcomes (1)
No secondary outcome.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporal ArteritisStudies of the same condition, open and under way.
- 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
- Case only
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Israel SA Heller, MD, Principal investigator, Tel Aviv Medical Center, Tel Aviv, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130857
- Sponsor's protocol ID
- 0123-09-TLV
- Status last verified
- Jan 2010
- First submitted
- 25 May 2010
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Tools in Temporal Arteritis - Towards the Development of a Diagnostic Algorithm
- ClinicalTrials.gov ID
- NCT01130857
- Acronym / sponsor ID
- 0123-09-TLV
- Conditions
- Temporal Arteritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 26 May 2010 (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.
Despite a large and growing body of knowledge concerning the diagnosis of temporal arteritis, this potentially crippling disease still requires pathological diagnosis in practically every case. It seems likely that a correctly estimated clinical probability could help in evaluating imaging results in a way that might safely obviate temporal biopsy in a large segment of suspect cases.
With this aim in view, we intend to identify useful clinical items and integrate them in an appropriate diagnostic pathway.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients suspected of temporal arteritis and referred to temporal artery biopsy
Key inclusion criteria (1 listed)
- Patients suspected of temporal arteritis and referred by their physicians to biopsy of a temporal artery.
Key exclusion criteria (1 listed)
- Pregnancy; age > 80 or < 18; unable to answer study questions
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
Percent decrease in future biopsy use.
Time frame: 2 years
1 secondary outcome
No secondary outcome.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
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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.
Ioni Tsechori, MD contact
Israel SA Heller, MD principal investigator
Tel Aviv Medical Center, Tel Aviv, ISRAEL
Questions about this trial
What is this clinical trial studying?
An observational study of Temporal Arteritis, run by Tel-Aviv Sourasky Medical Center.
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 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Israel SA Heller, MD (+97236973375/6, heller@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent decrease in future biopsy use. (time frame: 2 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 26 May 2010.