Asymptomatic General PopulationNCT01615315
Aspirin and the Risk of Microscopic Hematuria in Asymptomatic Screened Population
An observational study of Asymptomatic General Population and Microscopic Hematuria, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin treatment and hematuria in general population is not well known. The investigators will evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy large screened populations. Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Asymptomatic General Population, Microscopic Hematuria
- How many people
- 60,048 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Aug 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 20 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asymptomatic general population who underwent general health screening program
Who may be able to join
- Age ≥ 20 years, male or female
Who cannot join
- No result of urinalysis
- No record of medical history (including medication)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin treatment and hematuria in general population is not well known. The investigators will evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy large screened populations.
- Keywords
- aspirin, screening, microscopic hematuria
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of the microscopic hematuria
>4 RBC/HPF in urine microscopy
Measured: at the screening
Secondary outcomes (2)
Detection rate of significant cause for microscopic hematuria
- Among participants who had microscopic hematuria at the screening
- By imaging study or cystoscopy
- At the screening or within 12 months after screening
- Significant cause for microscopic hematuria
- urinary stone
- renal mass (benign or malignant / not simple cyst)
- urothelial cancer
- other lesions (clinically relevant lesions determined by researchers)
Measured: whitin 12 months after screening
Incidence rate of persistent microscopic hematuria
- Among participants who had microscopic hematuria at the screening
- Determined by repeated urine microscopy
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic General PopulationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 60,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Sang Eun Lee, Seoul National University Bundang Hospital
- Investigators
- Sang Eun Lee, selee@snubh.org, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615315
- Sponsor's protocol ID
- SNUBH-URO-2012-01
- Status last verified
- Aug 2012
- First submitted
- 6 Jun 2012
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin and the Risk of Microscopic Hematuria in Asymptomatic Screened Population
- ClinicalTrials.gov ID
- NCT01615315
- Acronym / sponsor ID
- SNUBH-URO-2012-01
- Keywords
- aspirin, screening, microscopic hematuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60,048 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Aug 2012
- Primary completion
- Aug 2012 (actual)
- First posted
- 8 Jun 2012 (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.
Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin treatment and hematuria in general population is not well known. The investigators will evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy large screened populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic general population who underwent general health screening program
Key inclusion criteria (1 listed)
- Age ≥ 20 years, male or female
Key exclusion criteria (2 listed)
- No result of urinalysis
- No record of medical history (including medication)
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
Incidence rate of the microscopic hematuria
Time frame: at the screening
>4 RBC/HPF in urine microscopy
2 secondary outcomes
Detection rate of significant cause for microscopic hematuria
Time frame: whitin 12 months after screening
Incidence rate of persistent microscopic hematuria
Time frame: within 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
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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.
Sang Eun Lee, selee@snubh.org principal investigator
Seoul National University Bundang Hospital
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 Asymptomatic General Population and Microscopic Hematuria, run by Seoul National University Hospital at 1 site in South Korea.
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: finished, as of the sponsor's last update on 28 Aug 2012. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence rate of the microscopic hematuria (time frame: at the screening). 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 28 Aug 2012.