Urinary Biomarkers Characteristic to Interstitial Cystitis
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 2, 2009 | ||||
| Last Updated Date | March 15, 2012 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00971568 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Urinary Biomarkers Characteristic to Interstitial Cystitis | ||||
| Official Title ICMJE | Urinary Biomarkers Characteristic to Interstitial Cystitis- Proteomic Analysis of Urine | ||||
| Brief Summary | 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. |
||||
| 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. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
||||
| Condition ICMJE | Interstitial Cystitis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 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- |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 15 | ||||
| Completion Date | September 2011 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00971568 | ||||
| Other Study ID Numbers ICMJE | 2009-163 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | William Beaumont Hospitals | ||||
| Study Sponsor ICMJE | William Beaumont Hospitals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | William Beaumont Hospitals | ||||
| Verification Date | March 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||