Chemokine Mechanisms in Chronic Pelvic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Praveen Thumbikat, Northwestern University
ClinicalTrials.gov Identifier:
NCT01676857
First received: August 29, 2012
Last updated: September 25, 2014
Last verified: September 2014

August 29, 2012
September 25, 2014
May 2010
June 2017   (final data collection date for primary outcome measure)
Correlation of cytokines/chemokines/proteins with CPPS symptoms [ Time Frame: Over the period of a year ] [ Designated as safety issue: No ]
Cytokines/chemokines/proteins will be correlated with symptom scores from patients in a longitudinal fashion.
Same as current
Complete list of historical versions of study NCT01676857 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Chemokine Mechanisms in Chronic Pelvic Pain
Chemokine Mechanisms in Chronic Pelvic Pain

The purpose of this study is to identify biomarkers that can be utilized in the diagnosis of chronic pelvic pain syndrome in men.

Chronic pelvic pain is the hallmark of patients with chronic pelvic pain syndrome (CPPS), a non-bacterial category of prostatitis that is a significant source of morbidity in American men. The cause of CPPS is unknown and there is a lack of convenient biomarkers for diagnosis of this syndrome. This project will examine the expression of biomarkers in expressed prostatic fluid from adult men with and without a diagnosis of CPPS. Thus our specific aim is to validate the use of the chemokines MCP-1 and MIP-1alpha and mast cell tryptase as biomarkers for CPPS in humans and correlate their levels with CPPS symptoms.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Expressed prostatic secretions, urine with or without cells, blood for cells and plasma

Non-Probability Sample

The Study population will include 176 adult patients diagnosed with CPPS (equal numbers of CPPS IIIa and CPPS IIIb) and 88 adult comparator controls, at least 18 years of age, recruited from Northwestern urology clinical site practices. All CPPS participants will be male and will have pelvic pain symptoms. Men who are at least 18 years of age and who had been seen by a physician for symptoms of CP/CPPS within the previous 2 years will comprise the patient population.

  • Chronic Prostatitis With Chronic Pelvic Pain Syndrome
  • Prostatitis
Not Provided
  • CP/CPPS group
    The Study population will include patients diagnosed with CPPS (equal numbers of CPPS IIIa and CPPS IIIb) at least 18 years of age, recruited from Northwestern urology clinical site practices. All CPPS participants will be male and will have pelvic pain symptoms. Men who are at least 18 years of age and who had been seen by a physician for symptoms of CP/CPPS within the previous 2 years will comprise the patient population
  • Control group
    Adult male volunteers who are male, at least 18 years of age and meet inclusion and exclusion criteria
Desireddi NV, Campbell PL, Stern JA, Sobkoviak R, Chuai S, Shahrara S, Thumbikat P, Pope RM, Landis JR, Koch AE, Schaeffer AJ. Monocyte chemoattractant protein-1 and macrophage inflammatory protein-1alpha as possible biomarkers for the chronic pelvic pain syndrome. J Urol. 2008 May;179(5):1857-61; discussion 1861-2. Epub 2008 Mar 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
264
June 2017
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • CP/CPPS group inclusion criteria

Patients are eligible for the study if they meet the following criteria:

  • Participant has signed and dated the appropriate Informed Consent document.
  • Agreed to participate in Study procedures.
  • Participant is at least 18 years of age.
  • Participant reports a response of at least 1 on the pain, pressure or discomfort scale (SYM-Q, Question #1).
  • Participant reports pain or discomfort in any of the 8 domains of the Male Genitourinary Pain Index (MGUPI) (items 1a, 1b, 1c, 1d, 2a, 2b, 2c, 2d).
  • These CP/CPPS symptoms been present for the majority of the time during any 3 months in the previous 6 months.

Exclusion Criteria:

  • Participant has an on-going symptomatic urethral stricture.
  • Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.

Participant has a history of cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy.

  • Participant has augmentation cystoplasty or cystectomy.
  • Participant has a history of cancer (with the exception of skin cancer).
  • Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).
  • Participant diagnosed with unilateral orchialgia, without pelvic symptoms.
  • Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.

Control group exclusion criteria In addition to the exclusion criteria listed above additional criteria for control subjects are as follows.

  1. In the past year, symptoms of discomfort or pain in the pelvic region for extended periods of time.
  2. Volunteers who have had a urinary tract infection with a urine culture value of >100,000 CFU/ml within the past three months.
  3. Volunteers treated with intravesical chemotherapy or BCG.
  4. Volunteers who have had any of the following sexually transmitted diseases (STDs) - gonorrhea, chlamydia, mycoplasma or trichomonas.
  5. Volunteers with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome)
Male
18 Years and older
Yes
Contact: Darlene Marko, RN 3126953898 d-marko@northwestern.edu
Contact: Praveen Thumbikat, PhD 3125031050 thumbikat@northwestern.edu
United States
 
NCT01676857
STU00030121, R01DK083609, R01DK094898
No
Praveen Thumbikat, Northwestern University
Northwestern University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Praveen Thumbikat, PhD Northwestern University
Northwestern University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP