ANCA-related VasculitisNCT01238003
Clinical Relevance of Anti-Neutrophil Cytoplasm Antibody (ANCA)in Hospitalized Patients
An observational study of ANCA-related Vasculitis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis of patients who have a high level of suspicion for ANCA-related vasculitis. In these patients the specificity and sensitivity to the ANCA test is very high. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ANCA-related Vasculitis
- What is being tested?
- Interpretation of blood test results
- How many people
- 380 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to Dec 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in internal medicine ward
Who may be able to join
- Blood samples sent for ANCA lab test
Who cannot join
- Patients with ANCA vasculitis
- Patients with known malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis of patients who have a high level of suspicion for ANCA-related vasculitis. In these patients the specificity and sensitivity to the ANCA test is very high. This study hopes to prove that when this lab test is performed on blood of patients who do not have a high level of suspicion for ANCA-related vasculitis, the sensitivity and specificity is reduced and there are many false positive results. Because of this, it should not be used as a screening test for a more general patient population.
- Conditions
- ANCA-related Vasculitis
- Being tested
- Interpretation of blood test results
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpretation of blood test resultsOther
Interpretation of blood test results
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients | Not described Receives: Other: Interpretation of blood test results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mostly negative lab results
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA-related VasculitisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238003
- Sponsor's protocol ID
- HYMC-10-0087
- Status last verified
- Nov 2010
- First submitted
- 9 Nov 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of Anti-Neutrophil Cytoplasm Antibody (ANCA)in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01238003
- Acronym / sponsor ID
- HYMC-10-0087
- Conditions
- ANCA-related Vasculitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 10 Nov 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.
Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis of patients who have a high level of suspicion for ANCA-related vasculitis. In these patients the specificity and sensitivity to the ANCA test is very high. This study hopes to prove that when this lab test is performed on blood of patients who do not have a high level of suspicion for ANCA-related vasculitis, the sensitivity and specificity is reduced and there are many false positive results. Because of this, it should not be used as a screening test for a more general patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients | – | Other: Interpretation of blood test results |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in internal medicine ward
Key inclusion criteria (1 listed)
- Blood samples sent for ANCA lab test
Key exclusion criteria (2 listed)
- Patients with ANCA vasculitis
- Patients with known malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpretation of blood test resultsInterpretation of blood test results | Other | Hospitalized patients |
Primary outcome
Mostly negative lab results
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 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.
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 ANCA-related Vasculitis, run by Hillel Yaffe 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 2 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 10 Nov 2010. 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?
Contact Nina Avshovich, MD (972-52-5566049, ninaa@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mostly negative lab results (time frame: One year). 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 10 Nov 2010.