DCC--INTERSTITIAL CYSTITIS CLINICAL TRIALS GROUP

Summary

Principal Investigator: J R Landis
Abstract: DESCRIPTION: (Abstract of the Application) This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Medical Center to serve as the Data Coordinating Center (DCC) for the Interstitial Cystitis Clinical Trials Group (ICCTG). The proposed DCC will provide administrative, biostatistical, urological, pathological, clinical data management and researc computing leadership for the ICCTG in the conduct of a series of randomized, controlled clinical trials (RCTs) at five Clinical Research Centers (CRCs) to investigate current and novel medical therapies for Interstitial Cystitis (IC) During Phase 1, the DCC will guide the design of ICCTG master protocols, including decisions related to baseline screening and data collection on symptoms, quality of life, and laboratory specimens, and during Phase 11, the DCC will guide the conduct of multiple RCTs. The DCC will provide expertise in the design and conduct of clinical trials, pain measurement, selection of outcome measures, and identification of prognostically different subgroups of patients. Based on completed analyses of data from the Interstitial Cystitis Data Base (ICDB) Study, as well as extensive new analyses underway at the CCEB a) identification of clusters of biopsy feature subgroups, b) correlating symptoms, clinical findings & family/medical history with biopsy specimen features), this DCC is uniquely positioned to provide valuable experience-base biostatistical leadership for the ICCTG during the planning phase of these clinical trials. The DCC will provide the clinical trials and biostatistics expertise for conducting specific clinical trial protocols, as illustrated by the two Protocols included in this proposal. To support these multi-center, multiple protocol RCTs, the DCC will provide the data management and research computing expertise necessary to design and implement data quality assurance, reporting and data collection via a secure World Wide Web (WWW)-based data management system, deployed on existing hardware at the CRCs, to facilitate data entry, verification and validation at the CRCs, and data transmission ove the Internet to the server at the DCC. This system will support subject enrollment, randomization and data collection at the CRCs, and tracking of subjects, data, and specimens at the DCC. The DCC will execute procedures for data security and access, data quality control, storage and back-up, and will provide periodic reports of accrual, follow-up, and data. The DCC will also provide the logistical and administrative support for the conduct of all multi center RCTs. The DCC will organize meetings of the Steering Committee, coordinate the development and distribution of the Protocol and Manual of Operations for each of the clinical trials, and provide the NIDDK Program Office, Steering Committee, External Advisory Committee, and Data and Safety Monitoring Board with interim data summaries, final statistical analyses and collaboration on all scientific publications.
Funding Period: 1998-05-10 - 2004-02-28
more information: NIH RePORT

Top Publications

  1. ncbi A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis
    Robert Mayer
    University of Rochester, Rochester, New York, USA
    J Urol 173:1186-91. 2005
  2. ncbi What is the pain of interstitial cystitis like?
    M P Fitzgerald
    Department of Urology, Loyola University Medical Center, Maywood, IL 60153, USA
    Int Urogynecol J Pelvic Floor Dysfunct 17:69-72. 2006
  3. ncbi Responsiveness of symptom scales for interstitial cystitis
    K J Propert
    University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104 6021, USA
    Urology 67:55-9. 2006
  4. ncbi Discovery of morphological subgroups that correlate with severity of symptoms in interstitial cystitis: a proposed biopsy classification system
    Benjamin E Leiby
    University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104 6021, USA
    J Urol 177:142-8. 2007
  5. ncbi Sexual function is a determinant of poor quality of life for women with treatment refractory interstitial cystitis
    J Curtis Nickel
    Department of Urology, Queen s University, Kingston General Hospital, Kingston, Ontario, Canada
    J Urol 177:1832-6. 2007
  6. ncbi Did patients with interstitial cystitis who failed to respond to initial treatment with bacillus Calmette-Guerin or placebo in a randomized clinical trial benefit from a second course of open label bacillus Calmette-Guerin?
    Kathleen Joy Propert
    Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Blockley Hall, 6th Floor, 423 Guardian Dr, Philadelphia, Pennsylvania 19104, USA
    J Urol 178:886-90. 2007
  7. ncbi Prospective evaluation of candidate urine and cell markers in patients with interstitial cystitis enrolled in a randomized clinical trial of Bacillus Calmette Guerin (BCG)
    Susan Keay
    Department of Medicine, University of Maryland School of Medicine, 10 N Greene Street, Baltimore, MD 21201, USA
    World J Urol 25:499-504. 2007
  8. pmc Followup of patients with interstitial cystitis responsive to treatment with intravesical bacillus Calmette-Guerin or placebo
    Kathleen Joy Propert
    University of Pennsylvania, Philadelphia, Pennsylvania, USA
    J Urol 179:552-5. 2008

Scientific Experts

  • Susan Keay
  • J C Nickel
  • M P Fitzgerald
  • K J Propert
  • Benjamin E Leiby
  • J Richard Landis
  • Robert Mayer
  • John E Tomaszewski
  • Harris E Foster
  • Leroy M Nyberg
  • Christopher K Payne
  • John Warren
  • John W Kusek
  • Daniel J Culkin
  • Edward M Messing
  • Philip Hanno
  • Grannum R Sant
  • Alan J Wein
  • Rosemary Madigan
  • Yawei Zhang
  • Kenneth M Peters
  • David Burks
  • Ananias Diokno

Detail Information

Publications8

  1. ncbi A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis
    Robert Mayer
    University of Rochester, Rochester, New York, USA
    J Urol 173:1186-91. 2005
    ..We compared intravesical bacillus Calmette-Guerin (BCG) to placebo instillations in patients with treatment refractory interstitial cystitis (IC)...
  2. ncbi What is the pain of interstitial cystitis like?
    M P Fitzgerald
    Department of Urology, Loyola University Medical Center, Maywood, IL 60153, USA
    Int Urogynecol J Pelvic Floor Dysfunct 17:69-72. 2006
    ....
  3. ncbi Responsiveness of symptom scales for interstitial cystitis
    K J Propert
    University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104 6021, USA
    Urology 67:55-9. 2006
    ....
  4. ncbi Discovery of morphological subgroups that correlate with severity of symptoms in interstitial cystitis: a proposed biopsy classification system
    Benjamin E Leiby
    University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104 6021, USA
    J Urol 177:142-8. 2007
    ..We identified morphologically distinct subgroups in interstitial cystitis using cluster analysis and investigated the associations between cluster membership and urinary symptoms...
  5. ncbi Sexual function is a determinant of poor quality of life for women with treatment refractory interstitial cystitis
    J Curtis Nickel
    Department of Urology, Queen s University, Kingston General Hospital, Kingston, Ontario, Canada
    J Urol 177:1832-6. 2007
    ..Interstitial cystitis significantly negatively impacts quality of life. The demographic and clinical factors associated with decreased quality of life in these patients have not been well studied...
  6. ncbi Did patients with interstitial cystitis who failed to respond to initial treatment with bacillus Calmette-Guerin or placebo in a randomized clinical trial benefit from a second course of open label bacillus Calmette-Guerin?
    Kathleen Joy Propert
    Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Blockley Hall, 6th Floor, 423 Guardian Dr, Philadelphia, Pennsylvania 19104, USA
    J Urol 178:886-90. 2007
    ....
  7. ncbi Prospective evaluation of candidate urine and cell markers in patients with interstitial cystitis enrolled in a randomized clinical trial of Bacillus Calmette Guerin (BCG)
    Susan Keay
    Department of Medicine, University of Maryland School of Medicine, 10 N Greene Street, Baltimore, MD 21201, USA
    World J Urol 25:499-504. 2007
    ..Changes in HDF and HB-EGF levels correlated weakly with changes in urgency, but the low BCG response rate prevented identification of additional associations between biomarker changes and treatment or symptoms...
  8. pmc Followup of patients with interstitial cystitis responsive to treatment with intravesical bacillus Calmette-Guerin or placebo
    Kathleen Joy Propert
    University of Pennsylvania, Philadelphia, Pennsylvania, USA
    J Urol 179:552-5. 2008
    ..We evaluated the longer term response in patients with interstitial cystitis who initially responded to intravesical bacillus Calmette-Guerin or placebo in a randomized clinical trial...