SinusitisNCT02071667
Association of Periostin Levels and Chronic Sinusitis
An observational study of Sinusitis and Nasal Polyps, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to see if a protein in blood, called periostin, can determine if patients have chronic sinusitis. This protein is in everyone's body, but the level of the protein may indicate certain conditions such as chronic sinusitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sinusitis, Nasal Polyps
- What is being tested?
- Blood draw
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are recommended for sinus surgery as part of their care who self report no asthma.
Who may be able to join
- Patients with sinus disease which requires surgical intervention
- Ability to understand and give informed consent
Who cannot join
- Previous diagnosis of asthma
- Positive methacholine challenge at screening
- Diagnosis of cystic fibrosis
- Concomitant use of systemic corticosteroids (except for those prescribed as part of standard pre-surgical treatment)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The purpose of this study is to see if a protein in blood, called periostin, can determine if patients have chronic sinusitis. This protein is in everyone's body, but the level of the protein may indicate certain conditions such as chronic sinusitis. The investigators are interested in testing levels of periostin to see if they are higher or lower than patients without chronic sinusitis, just as periostin is higher in patients with asthma. All patients enrolled in this study will have chronic sinusitis without asthma.
- Conditions
- Sinusitis, Nasal Polyps
- Being tested
- Blood draw
- Keywords
- Chronic sinusitis, Nasal Polyps
- Medical subject headings
- Sinusitis, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
| Study group | Role | What they receive |
|---|---|---|
| Subjects who require sinus surgery | Not described Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in circulating serum periostin levels pre and post sinus surgery
Serum collected prior to and following sinus surgery will be analyzed for concentrations of the protein periostin.
Measured: 10-15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionOct 2016
Why it stopped: Unable to recruit/enroll subjects for study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Steinke, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071667
- Sponsor's protocol ID
- 17123
- Status last verified
- May 2017
- First submitted
- 20 Feb 2014
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Periostin Levels and Chronic Sinusitis
- ClinicalTrials.gov ID
- NCT02071667
- Acronym / sponsor ID
- 17123
- Conditions
- Sinusitis, Nasal Polyps
- Keywords
- Chronic sinusitis, Nasal Polyps
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to recruit/enroll subjects for study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Feb 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.
The purpose of this study is to see if a protein in blood, called periostin, can determine if patients have chronic sinusitis. This protein is in everyone's body, but the level of the protein may indicate certain conditions such as chronic sinusitis. The investigators are interested in testing levels of periostin to see if they are higher or lower than patients without chronic sinusitis, just as periostin is higher in patients with asthma. All patients enrolled in this study will have chronic sinusitis without asthma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who require sinus surgery | – | Other: Blood draw |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are recommended for sinus surgery as part of their care who self report no asthma.
Key inclusion criteria (2 listed)
- Patients with sinus disease which requires surgical intervention
- Ability to understand and give informed consent
Key exclusion criteria (4 listed)
- Previous diagnosis of asthma
- Positive methacholine challenge at screening
- Diagnosis of cystic fibrosis
- Concomitant use of systemic corticosteroids (except for those prescribed as part of standard pre-surgical treatment)
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 |
|---|---|---|
| Blood draw | Other | Subjects who require sinus surgery |
Primary outcome
Difference in circulating serum periostin levels pre and post sinus surgery
Time frame: 10-15 weeks
Serum collected prior to and following sinus surgery will be analyzed for concentrations of the protein periostin.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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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 Sinusitis and Nasal Polyps, run by University of Virginia at 1 site in United States.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 4 May 2017. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Difference in circulating serum periostin levels pre and post sinus surgery (time frame: 10-15 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 4 May 2017.