Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisNCT02180126
Differing Levels of Positive Anti-Neutrophil Cytoplasm Antibody (ANCA) Test and Their Correlation With Vasculitis or Malignancy or Chronic Inflammation
An observational study of Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
A positive Anti-Neutrophil Cytoplasm Antibody (ANCA) test administered to patients with a high probability for vasculitis has high sensitivity and specificity for vasculitis. A positive ANCA test result in those patients who do not have a high probability for vasculitis requires extensive follow-up because those… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- What is being tested?
- Follow-up
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2014to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with borderline positive ANCA test results who had been hospitalized at the Hillel Yaffe Medical Center.
Who may be able to join
- Patients with borderline positive ANCA test results
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
A positive Anti-Neutrophil Cytoplasm Antibody (ANCA) test administered to patients with a high probability for vasculitis has high sensitivity and specificity for vasculitis. A positive ANCA test result in those patients who do not have a high probability for vasculitis requires extensive follow-up because those patients eventually present with malignancy or other inflammatory diseases. The investigators wish to investigate the correlation between the differing levels of positive ANCA tests and their relationship to vasculitis, malignancy and inflammatory diseases.
- Being tested
- Follow-up
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
Follow-up of of patients with borderline positive ANCA test results
| Study group | Role | What they receive |
|---|---|---|
| Positive ANCA | Patients with borderline positive ANCA results. Receives: Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Borderline Positive ANCA
Borderline positive ANCA results of 12-19 U/ml is indication of possible malignancy or inflammatory diseases
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Neutrophil Cytoplasmic Antibody-Associated 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nina Avshovich, MD, Study director, Hillel Yaffe Medical CenterTatiana Sivan, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180126
- Sponsor's protocol ID
- HYMC0041-14
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2014
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differing Levels of Positive Anti-Neutrophil Cytoplasm Antibody (ANCA) Test and Their Correlation With Vasculitis or Malignancy or Chronic Inflammation
- ClinicalTrials.gov ID
- NCT02180126
- Acronym / sponsor ID
- HYMC0041-14
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 2 Jul 2014 (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.
A positive Anti-Neutrophil Cytoplasm Antibody (ANCA) test administered to patients with a high probability for vasculitis has high sensitivity and specificity for vasculitis. A positive ANCA test result in those patients who do not have a high probability for vasculitis requires extensive follow-up because those patients eventually present with malignancy or other inflammatory diseases. The investigators wish to investigate the correlation between the differing levels of positive ANCA tests and their relationship to vasculitis, malignancy and inflammatory diseases.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive ANCA | – | Other: Follow-upPatients with borderline positive ANCA results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with borderline positive ANCA test results who had been hospitalized at the Hillel Yaffe Medical Center.
Key inclusion criteria (1 listed)
- Patients with borderline positive ANCA test results
Key exclusion criteria (1 listed)
- Pregnant
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 |
|---|---|---|
| Follow-upFollow-up of of patients with borderline positive ANCA test results | Other | Positive ANCA |
Primary outcome
Borderline Positive ANCA
Time frame: Two weeks
Borderline positive ANCA results of 12-19 U/ml is indication of possible malignancy or inflammatory diseases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
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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.
Nina Avshovich, MD study director
Hillel Yaffe Medical Center
Tatiana Sivan, MD principal investigator
Hillel Yaffe Medical Center
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 Anti-Neutrophil Cytoplasmic Antibody-Associated 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 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 2 Jul 2014. 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 Tatiana Sivan, MD (972-4-630-4648, dk5@smile.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borderline Positive ANCA (time frame: Two weeks). 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 2 Jul 2014.