Neoplasms, ProstateRESPECTNCT01371513
Korean Practice Patterns for Screening PCA(Prostate Cancer)
An observational study of Neoplasms, Prostate and Prostate Cancer, run by GlaxoSmithKline at 1 site in South Korea.
Trial summary
This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Neoplasms, Prostate, Prostate Cancer, Benign Prostatic Hyperplasia
- What is being tested?
- continuous screening
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Jun 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with PSA more than 2.5ng/ml in 2008 from urology department of clinic and general hospital
Who may be able to join
- Male with PSA more than 2.5ng/ml from 1 Jan 2008 to 31 Dec 2008
Who cannot join
- Age less than 40 at PSA screening
- History of drug use which can affect level of PSA within 6months before PSA screening
- Subject who participate any other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Korean's Practice Patterns for Screening PCA(Prostate Cancer) According to PSA(Prostate-specific Antigen) Level
This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.
Read the detailed description
This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.
- Being tested
- continuous screening
- Keywords
- Serum prostate specific antigen
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous screeningOther
practice patterns for screening prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| PSA level | more than 2.5ng/ml Receives: Other: continuous screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with prostate biopsy
Measured: 1year
Secondary outcomes (1)
Number of subjects with prostate cancer
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, ProstateStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371513
- Sponsor's protocol ID
- 113951
- Acronym
- RESPECT
- Status last verified
- May 2017
- First submitted
- 12 May 2011
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean's Practice Patterns for Screening PCA(Prostate Cancer) According to PSA(Prostate-specific Antigen) Level
- ClinicalTrials.gov ID
- NCT01371513
- Acronym / sponsor ID
- RESPECT / 113951
- Keywords
- Serum prostate specific antigen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Jun 2011 (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.
This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.
Detailed description
This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSA level | – | Other: continuous screeningmore than 2.5ng/ml |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with PSA more than 2.5ng/ml in 2008 from urology department of clinic and general hospital
Key inclusion criteria (1 listed)
- Male with PSA more than 2.5ng/ml from 1 Jan 2008 to 31 Dec 2008
Key exclusion criteria (3 listed)
- Age less than 40 at PSA screening
- History of drug use which can affect level of PSA within 6months before PSA screening
- Subject who participate any other clinical trial
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 |
|---|---|---|
| continuous screeningpractice patterns for screening prostate cancer | Other | PSA level |
Primary outcome
Number of subjects with prostate biopsy
Time frame: 1year
1 secondary outcome
Number of subjects with prostate cancer
Time frame: 1year
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 22 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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Neoplasms, Prostate and Prostate Cancer, run by GlaxoSmithKline 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 3 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 22 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 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?
Number of subjects with prostate biopsy (time frame: 1year). 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 22 May 2017.