<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01676857</url>
  </required_header>
  <id_info>
    <org_study_id>STU00030121</org_study_id>
    <secondary_id>R01DK083609</secondary_id>
    <secondary_id>R01DK094898</secondary_id>
    <nct_id>NCT01676857</nct_id>
  </id_info>
  <brief_title>Chemokine Mechanisms in Chronic Pelvic Pain</brief_title>
  <official_title>Chemokine Mechanisms in Chronic Pelvic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify biomarkers that can be utilized in the diagnosis of&#xD;
      chronic pelvic pain syndrome in men.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic pelvic pain is the hallmark of patients with chronic pelvic pain syndrome (CPPS), a&#xD;
      non-bacterial category of prostatitis that is a significant source of morbidity in American&#xD;
      men. The cause of CPPS is unknown and there is a lack of convenient biomarkers for diagnosis&#xD;
      of this syndrome. This project will examine the expression of biomarkers in expressed&#xD;
      prostatic fluid from adult men with and without a diagnosis of CPPS. Thus our specific aim is&#xD;
      to validate the use of the chemokines MCP-1 and MIP-1alpha and mast cell tryptase as&#xD;
      biomarkers for CPPS in humans and correlate their levels with CPPS symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">January 24, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of cytokines/chemokines/proteins with CPPS symptoms</measure>
    <time_frame>Over the period of a year</time_frame>
    <description>Cytokines/chemokines/proteins will be correlated with symptom scores from patients in a longitudinal fashion.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">147</enrollment>
  <condition>Chronic Prostatitis With Chronic Pelvic Pain Syndrome</condition>
  <condition>Prostatitis</condition>
  <arm_group>
    <arm_group_label>CP/CPPS group</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Adult male volunteers who are male, at least 18 years of age and meet inclusion and exclusion criteria</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Expressed prostatic secretions, urine with or without cells, blood for cells and plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The Study population will include 176 adult patients diagnosed with CPPS (equal numbers of&#xD;
        CPPS IIIa and CPPS IIIb) and 88 adult comparator controls, at least 18 years of age,&#xD;
        recruited from Northwestern urology clinical site practices. All CPPS participants will be&#xD;
        male and will have pelvic pain symptoms. Men who are at least 18 years of age and who had&#xD;
        been seen by a physician for symptoms of CP/CPPS within the previous 2 years will comprise&#xD;
        the patient population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CP/CPPS group inclusion criteria&#xD;
&#xD;
        Patients are eligible for the study if they meet the following criteria:&#xD;
&#xD;
          -  Participant has signed and dated the appropriate Informed Consent document.&#xD;
&#xD;
          -  Agreed to participate in Study procedures.&#xD;
&#xD;
          -  Participant is at least 18 years of age.&#xD;
&#xD;
          -  Participant reports a response of at least 1 on the pain, pressure or discomfort scale&#xD;
             (SYM-Q, Question #1).&#xD;
&#xD;
          -  Participant reports pain or discomfort in any of the 8 domains of the Male&#xD;
             Genitourinary Pain Index (MGUPI) (items 1a, 1b, 1c, 1d, 2a, 2b, 2c, 2d).&#xD;
&#xD;
          -  These CP/CPPS symptoms been present for the majority of the time during any 3 months&#xD;
             in the previous 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has an on-going symptomatic urethral stricture.&#xD;
&#xD;
          -  Participant has an on-going neurological disease or disorder affecting the bladder or&#xD;
             bowel fistula.&#xD;
&#xD;
        Participant has a history of cystitis caused by tuberculosis, radiation therapy or&#xD;
        Cytoxan/cyclophosphamide therapy.&#xD;
&#xD;
          -  Participant has augmentation cystoplasty or cystectomy.&#xD;
&#xD;
          -  Participant has a history of cancer (with the exception of skin cancer).&#xD;
&#xD;
          -  Participant has current major psychiatric disorder or other psychiatric or medical&#xD;
             issues that would interfere with study participation (e.g. dementia, psychosis,&#xD;
             upcoming major surgery, etc).&#xD;
&#xD;
          -  Participant diagnosed with unilateral orchialgia, without pelvic symptoms.&#xD;
&#xD;
          -  Participant has a history of transurethral microwave thermotherapy (TUMT),&#xD;
             transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or&#xD;
             laser procedure.&#xD;
&#xD;
        Control group exclusion criteria In addition to the exclusion criteria listed above&#xD;
        additional criteria for control subjects are as follows.&#xD;
&#xD;
          1. In the past year, symptoms of discomfort or pain in the pelvic region for extended&#xD;
             periods of time.&#xD;
&#xD;
          2. Volunteers who have had a urinary tract infection with a urine culture value of&#xD;
             &gt;100,000 CFU/ml within the past three months.&#xD;
&#xD;
          3. Volunteers treated with intravesical chemotherapy or BCG.&#xD;
&#xD;
          4. Volunteers who have had any of the following sexually transmitted diseases (STDs) -&#xD;
             gonorrhea, chlamydia, mycoplasma or trichomonas.&#xD;
&#xD;
          5. Volunteers with inflammatory bowel disease (such as Crohn's disease or ulcerative&#xD;
             colitis, but not irritable bowel syndrome)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Praveen Thumbikat, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern Medical Faculty Foundation</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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. doi: 10.1016/j.juro.2008.01.028. Epub 2008 Mar 18.</citation>
    <PMID>18353390</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Praveen Thumbikat</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>chronic pain, prostatitis, pelvic pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatitis</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01676857
org study id: STU00030121
secondary id: R01DK083609
secondary id: R01DK094898
nct id: NCT01676857
lead sponsor: 
collaborator: 
has dmc: No
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 model: Cohort
time perspective: Prospective
measure: Correlation of cytokines/chemokines/proteins with CPPS symptoms
time frame: Over the period of a year
description: Cytokines/chemokines/proteins will be correlated with symptom scores from patients in a longitudinal fashion.
arm group label: CP/CPPS group
description: 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
arm group label: Control group
description: Adult male volunteers who are male, at least 18 years of age and meet inclusion and exclusion criteria
Expressed prostatic secretions, urine with or without cells, blood for cells and plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Praveen Thumbikat, PhD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
citation: 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. doi: 10.1016/j.juro.2008.01.028. Epub 2008 Mar 18.
PMID: 18353390
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Praveen Thumbikat
investigator title: Assistant Professor
mesh term: Prostatitis
mesh term: Pelvic Pain