Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000792729
Ethics application status
Approved
Date submitted
11/07/2013
Date registered
16/07/2013
Date last updated
10/10/2022
Date data sharing statement initially provided
10/10/2022
Date results provided
10/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
immune investigation in patients with chronic prostatitis
Scientific title
Differential expression of serum IgA,IgM, IgG,CD4 and CD8 between patients with chronic prostatitis and healthy controls
Secondary ID [1] 282809 0
Nil
Universal Trial Number (UTN)
U1111-1145-4774
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic prostatitis 289584 0
Condition category
Condition code
Renal and Urogenital 289918 289918 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
investigating the difference of serum marker including IgA, IgM,IgG,CD4 and CD8 between patients with chronic prostatitis and healthy population; participants are asked to give a blood sample on one occasion only immediately after their diagnosis of chronic prostatitis or their involving in the study as the healthy controls
Intervention code [1] 287493 0
Not applicable
Comparator / control treatment
serum IgA, IgM,IgG,CD4 and CD8 were investigated in healthy population
Control group
Active

Outcomes
Primary outcome [1] 289972 0
serum immune marker including serum IgA, IgM, IgG, CD4 and CD8 was assayed
Timepoint [1] 289972 0
immediately after the diagnosis
Secondary outcome [1] 303688 0
symptom score ( NIH-CPSI) was evaluated
Timepoint [1] 303688 0
immediately after the diagnosis

Eligibility
Key inclusion criteria
the history of prostate pain longer than 3 months;age between 18 and 45; normal urin routine and negative urine culture
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
prostatitis(I,II, IV); the pain not from chronic prostatitis but related to the other pelvic diseases

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2013
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
10/04/2014
Date of last data collection
Anticipated
Actual
10/07/2014
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 5181 0
China
State/province [1] 5181 0
shanghai

Funding & Sponsors
Funding source category [1] 287587 0
Hospital
Name [1] 287587 0
changhai hospital 1255 grant
Country [1] 287587 0
China
Primary sponsor type
Individual
Name
Tie Zhou
Address
urology department, changhai hospital
changhai road 168#, shanghai, China, 200433
Country
China
Secondary sponsor category [1] 286334 0
None
Name [1] 286334 0
Address [1] 286334 0
Country [1] 286334 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289560 0
changhai ethic comittee
Ethics committee address [1] 289560 0
Ethics committee country [1] 289560 0
China
Date submitted for ethics approval [1] 289560 0
20/04/2013
Approval date [1] 289560 0
28/04/2013
Ethics approval number [1] 289560 0
CHEC2013-056

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41330 0
A/Prof Tie Zhou
Address 41330 0
urology department, changhai hospital,
changhai road 168#, shanghai, China,200433
Country 41330 0
China
Phone 41330 0
+862113918360523
Fax 41330 0
Email 41330 0
[email protected]
Contact person for public queries
Name 41331 0
Zhou tie
Address 41331 0
urology department, changhai hospital,
changhai road 168#, shanghai, China,200433
Country 41331 0
China
Phone 41331 0
+862113918360523
Fax 41331 0
Email 41331 0
[email protected]
Contact person for scientific queries
Name 41332 0
zhou tie
Address 41332 0
urology department, changhai hospital,
changhai road 168#, shanghai, China,200433
Country 41332 0
China
Phone 41332 0
+862113918360523
Fax 41332 0
Email 41332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Zhang W, Fang Y, Shi M, Zhang M, Chen Y, Zhou T. O... [More Details] 364568-(Uploaded-05-10-2022-00-08-35)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.