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MARQUEE Interim Reports – 2014

Does Mucosal Healing Matter for Clinically Quiescent Ulcerative Colitis?

Update May 2014

AIMS

Primary Aims

  1. To determine the prevalence of active endoscopic mucosal disease, defined by the Mayo endoscopic subscore, UCEIS, and UCCIS, in patients with clinically quiescent UC undergoing routine surveillance colonoscopy, both prior to and after stratification by baseline UC medication class (5-ASA, thiopurine, anti-TNF)
  2. To determine the prevalence of active histological disease (both acute and chronic inflammation), defined by the Riley Index and basal plasmacytosis, in patients with clinically quiescent UC undergoing routine surveillance colonoscopy, both prior to and after stratification by baseline UC medication class (5-ASA, thiopurine, anti-TNF)
  3. To correlate the endoscopic findings with histological findings of acute and chronic inflammation

 

Secondary Aims

  1. To preliminarily determine the risk of clinical relapse by Mayo endoscopic subscore, UCEIS, and UCCIS, in patients with clinically quiescent UC undergoing routine surveillance colonoscopy, both prior to and after stratification by baseline UC medication class
  2. To preliminarily determine the risk of clinical relapse by Riley Index and basal plasmacytosis in patients with clinically quiescent UC undergoing routine surveillance colonoscopy, both prior to and after stratification by baseline UC medication class

 

STATUS UPDATE

Five sites are involved in the pilot study: University of Pennsylvania (primary), University of North Carolina, University of Michigan, University of Maryland, and Beth Israel Deaconness Medical Center.  The protocol has been IRB-approved at all sites.  Contracts are nearly finalized at all sites.  The database is finalized and has been tested.  Endoscopic video recording techniques are almost finalized at all site.  Start of enrollment is projected to be April 2014.