Urinary Biomarkers Characteristic to Interstitial Cystitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00971568
First received: September 2, 2009
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

This is a retrospective study of urine samples stored in the Beaumont BioBank for future research. The urine samples will be drawn from the urine back with patients previously diagnosed with severe interstitial cystitis (IC), mild IC and no IC.

Interstitial Cystitis (IC) also known as Painful Bladder Syndrome (PBS) is a chronic inflammatory disease. It has an unknown etiology, symptoms which present to varying degrees, as well as an uncertain natural history. Diagnosis of IC is based on symptoms after excluding more common and dangerous pathologies.


Condition
Interstitial Cystitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Urinary Biomarkers Characteristic to Interstitial Cystitis- Proteomic Analysis of Urine

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Using a ProteinChip SELDI--TOF (surface enhanced laser desorption ionisation-time of flight) mass spectrometer, we will analyze previously collected urine samples from matched patients with severe IC, mild IC and controls without disease. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Urine sample
To prepare for SELDI-TOF we will use 15 samples. Each sample (25ul) will be analyzed with the Luminex 100 IS (MiraiBio, South San Francisco, CA) using a LINCOplex cytokine/che-

Detailed Description:

Extensive research has been done to understand the multifactorial etiology as well as to help diagnose IC. Infectious, autoimmune and anatomic causes have been looked at with few usable results. Inflammatory cells and markers have been more productive. Recently we have shown in the rat model, that chemically induced inflammation, yields temporal increases in measurable cytokines and chemokines in the urine. Moreover, this was done by Multiplex analysis, using a multiple antigen bead assay (Luminex).

Cytokines and chemokines, part of an organisms proteome, allow for looking at the function of a cell or organ at the time of the collection United States: Institutional Review Board. Urine is obtained non-invasively and yields significant information about urinary tract organs. The ability to find a biomarker or pattern of biomarker in the urine, diagnostic to a disease, offers significant advantages over serum or tissue diagnosis.

We hope to identify patterns of inflammatory markers using proteomic analysis using the previously mentioned multiple antigen cassettes (Luminex) as well as identify possible new biomarkers using a Protein Chip SELDI--TOF (surface enhanced laser desorption ionisation-time of flight) mass spectrometer. The detection of patterns or new biomarkers has promise to help with diagnosis, treatment, and ultimately revealing the etiology and course of IC.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We will be examining urine already collected and in the Beaumont Biobank. The urine to be examined is from patients with known severe Interstitial Cystitis (IC), mild IC or known to not have the disease.

Criteria

Inclusion Criteria:

  • Patients who have previously been contacted and consented to place a sample within the biobank. We will select five representative patients from the severe IC diagnosis, mild IC diagnosis, and no IC diagnosis, and we will match these patients as best as possible within the limited biobank samples.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971568

Locations
United States, Michigan
Beaumont Hospitals-Royal Oak
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Michael Chancellor, MD Beaumont Hospitals
  More Information

No publications provided

Responsible Party: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00971568     History of Changes
Other Study ID Numbers: 2009-163
Study First Received: September 2, 2009
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Interstitial cystitis
Painful bladder syndrome

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 01, 2014