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 information initially 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
changhai road 168#, shanghai, China, 200433
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
By comparing the serum immune marker between patients with chronic prostatitis and healthy controls to investigate the relationship of immune status to chronic prostatitis
Trial website
Trial related presentations / publications

Int Urol Nephrol. 2018 Mar;50(3):395-399.
doi: 10.1007/s11255-017-1763-z. Epub 2017 Dec 12.
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
A/Prof 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
A/Prof 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.