Prostate CancerNCT01614548
Management of Prostate Cancer in Central China
An observational study of Prostate Cancer, run by Zhengzhou University at 1 site in China.
Trial summary
Some recent reports indicate that incidence of prostate cancer is increasing rapidly in China. However, no large-scale survey of prostate cancer has been done in central China, few data are available regarding its management. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 789 participants
- Where
- 1 siteChina
- Study dates
- Jan 2003to 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: all inpatients with prostate cancer in 14 hospitals
Who may be able to join
- patients with newly diagnosed prostate cancer were included in the study. Exclusion Criteria:
- Those with a history of prostate cancer who were treated for another disease were excluded from study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
the first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Comparisons of Management and Outcome of Prostate Cancer in Central China Between 2003 and 2008: A Multi-institutional Report
Some recent reports indicate that incidence of prostate cancer is increasing rapidly in China. However, no large-scale survey of prostate cancer has been done in central China, few data are available regarding its management. The investigators aimed to analyze the management of prostate cancer and compare the outcome of patients with such a survey.
The investigators collected data of patients diagnosed with prostate cancer from the 2003 and 2008 in central China. Data were disaggregated by rural and urban hukou. The survival rate of patients was analyzed using Kaplan-Meier method. Prognostic factors were analyzed using the log-rank test and Cox proportional hazards model.
- Conditions
- Prostate Cancer
- Keywords
- Prostatic Neoplasms, Prostate Cancer, Disease Management, Rural, Urban
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all patients | We selected 9 cities (Zhengzhou, Luoyang, Kaifeng, Anyang, Xinyang, Zhoukou, Shangqiu, Nanyang, Zhumadian) by probability proportional to size sampling from geographical regions in central China. All cases with complete follow-up data of histological-proven prostate cancer treated in 2003 and 2008 at 14 department of urology in the 9 cities were retrospectively collected. Only patients with newly diagnosed prostate cancer were included in the study. Those with a history of prostate cancer who were treated for another disease were excluded from study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
overall survival that was defined as the interval from the date of diagnosis to the Medicare date of death
Measured: 3 years
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 startJan 2003
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- 789 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Henan Cancer Hospital, Third Affiliated Hospital of Zhengzhou University, People's Hospital of Zhengzhou University, Xinyang Central Hospital, Zhoukou Central Hospital, Center hospital of Nanyang, Center hospital of Shangqiu, Zhumadian Central Hospital, Anyang Regional Hospital, Luoyang Central Hospital, First People's Hospital of Kaifeng
- Responsible party
- Principal investigator, Liu Bingqian, Zhengzhou University
- Investigators
- Liu Bingqian, Ph.D MD, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614548
- Sponsor's protocol ID
- ZZU2012
- Status last verified
- Jun 2012
- First submitted
- 2 Jun 2012
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Management and Outcome of Prostate Cancer in Central China Between 2003 and 2008: A Multi-institutional Report
- ClinicalTrials.gov ID
- NCT01614548
- Acronym / sponsor ID
- ZZU2012
- Conditions
- Prostate Cancer
- Keywords
- Prostatic Neoplasms, Prostate Cancer, Disease Management, Rural, Urban
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 789 participants (actual)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Henan Cancer Hospital, Third Affiliated Hospital of Zhengzhou University, People's Hospital of Zhengzhou University, Xinyang Central Hospital, Zhoukou Central Hospital, Center hospital of Nanyang, Center hospital of Shangqiu, Zhumadian Central Hospital, Anyang Regional Hospital, Luoyang Central Hospital, First People's Hospital of Kaifeng
- Study start
- Jan 2003
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (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.
Some recent reports indicate that incidence of prostate cancer is increasing rapidly in China. However, no large-scale survey of prostate cancer has been done in central China, few data are available regarding its management. The investigators aimed to analyze the management of prostate cancer and compare the outcome of patients with such a survey.
The investigators collected data of patients diagnosed with prostate cancer from the 2003 and 2008 in central China. Data were disaggregated by rural and urban hukou. The survival rate of patients was analyzed using Kaplan-Meier method. Prognostic factors were analyzed using the log-rank test and Cox proportional hazards model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | – | –We selected 9 cities (Zhengzhou, Luoyang, Kaifeng, Anyang, Xinyang, Zhoukou, Shangqiu, Nanyang, Zhumadian) by probability proportional to size sampling from geographical regions in central China. All cases with complete follow-up data of histological-proven prostate cancer treated in 2003 and 2008 at 14 department of urology in the 9 cities were retrospectively collected. Only patients with newly diagnosed prostate cancer were included in the study. Those with a history of prostate cancer who were treated for another disease were excluded from study. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all inpatients with prostate cancer in 14 hospitals
Key inclusion criteria (2 listed)
- patients with newly diagnosed prostate cancer were included in the study. Exclusion Criteria:
- Those with a history of prostate cancer who were treated for another disease were excluded from study.
Key exclusion criteria (0 listed)
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
overall survival
Time frame: 3 years
overall survival that was defined as the interval from the date of diagnosis to the Medicare date of death
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 8 Jun 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.
Liu Bingqian, Ph.D MD principal investigator
The First Affiliated Hospital of Zhengzhou University
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 Prostate Cancer, run by Zhengzhou University at 1 site in China.
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 0 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 8 Jun 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 China. 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?
overall survival (time frame: 3 years). 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 8 Jun 2012.