Utility of random biopsies in inflammatory bowel disease

Active Cooperative Agreement Awarded Last action

Award ID
U01DK138901
Recipient
Awarding agency
Obligated
$7,655,738

Award facts

Completion date 46% complete
Place of performance
Philadelphia, PA 19104, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Patients with long standing inflammatory bowel diseases (IBD) have an increased risk of colorectal cancer (CRC) as a consequence of chronic inflammation. To reduce morbidity and mortality from IBD-related CRC, surveillance for precancerous dysplasia with colonoscopy is recommended every 1-3 years beginning 8-10 years after diagnosis for most patients with IBD. However, the most effective way to perform dysplasia surveillance has not been definitively established. IBD-associated precancerous dysplastic lesions may represent a field effect from chronic inflammation and are difficult to see with standard definition white light colonoscopy. Fortunately, the advent of high-definition white light colonoscopy (hdwlc) improved our ability to visualize and remove precancerous dysplastic lesions. Nonetheless, the historical practice of collecting four untargeted random mucosal biopsies every 10 CM throughout the colon continues to be widely employed for patients with IBD. The rationale is that random biopsies may help detect these difficult to see precancerous lesions. However, the recommendations for this practice are based on uncontrolled observations and EX-vivo studies of resected specimen. In the one small randomized clinical trial to test the efficacy of random biopsies, the rate of dysplasia detection was numerically higher in the patients only getting targeted biopsies. This has led to equipoise regarding random biopsies. The proposed utility of random biopsies in inflammatory bowel disease (urbi) trial will be a multicenter pragmatic randomized clinical trial among 1642 patients to definitively assess whether a limited biopsy strategy obtaining only two random biopsies from two locations is non-inferior to the practice of obtaining four random biopsies every 10CM throughout the colon among patients with IBD undergoing dysplasia surveillance with hdwlc. The primary outcome will be the average number of dysplastic and sessile serrated adenoma lesions detected per colonoscopy. The urbi trial will also present an opportunity to study the biology of colitis-associated dysplasia. Dysplasia is graded as absent, low-grade (LGD) or high-grade (HGD). Indefinite for dysplasia (IFD) is used when there is uncertainty whether or not there is LGD. Better understanding the biology of the dysplasia sequence could improve pathologic classification and minimizing the need for the IFD category. Yet, little research has been done to understand the progression of inflammation to dysplasia or the molecular characteristics of IFD using modern omics technologies. We will utilize spatial transcriptomics and an integrative analytic approach to inform the biologic progression from inflammation to HGD, including the biology of IFD. The biopsy samples and linked clinical data collected in the urbi trial will provide an ideal resource to study the molecular biology of colitis-associated dysplasia and IFD. Thus, the urbi trial will establish best practices for IBD dysplasia surveillance and advance our understanding of the biology of colitis-associated dysplasia.

Transactions

Action Obligated Date
Amendment $2,624,225
Amendment $2,620,533
Original award $2,410,980

Subawards

Subrecipient Amount Awarded
Northwestern University "Site Northwestern University This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $50,000
University Of Alabama At Birmingham "Site University of Alabama at Birmingham This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $74,000
Scripps Health "Site Scripps Health This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $250,000
The Regents Of The University Of Colorado "Site Regents of the University of Colorado This site will employ their best efforts in the performance of the work requirements listed below and provide data… $50,000
University Of Rochester "Site University of Rochester This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $50,000
Mayo Clinic "This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials essential to the performance… $50,000
Mayo Clinic Jacksonville (A Nonprofit Corporation) "Site Mayo Clinic Jacksonville This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $74,000
Mercy Medical Center Inc. "Site Mercy Medical Center Inc This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $50,000
Allegheny Singer Research Institute "Site Allegheny-Singer Research Institute This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $50,000
Weill Medical College Of Cornell University "Site Weill Medical College of Cornell University This site will employ their best efforts in the performance of the work requirements listed below and… $54,800
University Of Pittsburgh - Of The Commonwealth System Of Higher Education "Site University of Pittsburgh This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $50,000
University Of Alabama At Birmingham "Site University of Alabama at Birmingham This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $50,000
Northwestern University "Site Northwestern University This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $48,000
New York University "Site NEW YORK UNIVERSITY GROSSMAN SCHOOL OF MEDICINE This site will employ their best efforts in the performance of the work requirements listed below and… $48,000
University Of North Carolina Hospitals At Chapel Hill "Site University of North Carolina at Chapel Hill This site will employ their best efforts in the performance of the work requirements listed below and… $48,000
University Of Utah "Site University of Utah This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $36,000
Mayo Clinic Jacksonville (A Nonprofit Corporation) "Site Mayo Clinic Jacksonville This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $48,000
Regents Of The University Of Michigan "Site Regents of the University of Michigan This site will employ their best efforts in the performance of the work requirements listed below and provide data… $50,000
University Of Rochester "Site University of Rochester This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $48,000
Mercy Medical Center Inc. "Site Mercy Medical Center Inc This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $48,000
The Regents Of The University Of Colorado "Site Regents of the University of Colorado This site will employ their best efforts in the performance of the work requirements listed below and provide data… $48,000
University Of California, LOS Angeles "Site University of California, Los Angeles This site will employ their best efforts in the performance of the work requirements listed below and provide data… $48,000
Mayo Clinic "This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials essential to the performance… $48,000
Allegheny Singer Research Institute "Site Allegheny-Singer Research Institute This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $50,000
Icahn School Of Medicine At Mount Sinai "Site Icahn School of Medicine at Mount Sinai This site will employ their best efforts in the performance of the work requirements listed below and provide data… $50,000
Scripps Health "Site Scripps Health This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $50,000
The Methodist Hospital Research Institute "This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials essential to the performance… $50,000
The Regents Of The University Of Colorado "Site Regents of the University of Colorado This site will employ their best efforts in the performance of the work requirements listed below and provide data… $50,000
Adventist Health System / Sunbelt Inc. "Site Adventist Health System/Sunbelt, Inc. dba Advent Health Orlando This site will employ their best efforts in the performance of the work requirements… $50,000
University Of Miami "Site University of Miami This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $50,000
Mercy Medical Center Inc. "Site Mercy Medical Center Inc This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $50,000
University Of Pittsburgh - Of The Commonwealth System Of Higher Education "Site University of Pittsburgh This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $54,800
New York University "Site NEW YORK UNIVERSITY GROSSMAN SCHOOL OF MEDICINE This site will employ their best efforts in the performance of the work requirements listed below and… $50,000
Allegheny Singer Research Institute "Site Allegheny-Singer Research Institute This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $50,000
University Of North Carolina Hospitals At Chapel Hill "Site University of North Carolina at Chapel Hill This site will employ their best efforts in the performance of the work requirements listed below and… $50,000
University Of California, LOS Angeles "Site University of California, Los Angeles This site will employ their best efforts in the performance of the work requirements listed below and provide data… $50,000
Northwestern University "Site Northwestern University This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $50,000
University Of Rochester "Site University of Rochester This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $50,000
University Of Utah "Site University of Utah This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $50,000
Mayo Clinic "This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials essential to the performance… $50,000
Mayo Clinic Jacksonville (A Nonprofit Corporation) "Site Mayo Clinic Jacksonville This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $50,000
Icahn School Of Medicine At Mount Sinai "Site Icahn School of Medicine at Mount Sinai This site will employ their best efforts in the performance of the work requirements listed below and provide data… $54,800
Regents Of The University Of Michigan "Site Regents of the University of Michigan This site will employ their best efforts in the performance of the work requirements listed below and provide data… $54,800
New York University "Site NEW YORK UNIVERSITY GROSSMAN SCHOOL OF MEDICINE This site will employ their best efforts in the performance of the work requirements listed below and… $54,800
Mercy Medical Center Inc. "Site Mercy Medical Center Inc This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $54,800
Scripps Health "Site Scripps Health This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $54,800
University Of Alabama At Birmingham "Site University of Alabama at Birmingham This site will employ their best efforts in the performance of the work requirements listed below and provide data and… $54,800
Adventist Health System / Sunbelt Inc. "Site Adventist Health System/Sunbelt, Inc. dba Advent Health Orlando This site will employ their best efforts in the performance of the work requirements… $54,800
The Methodist Hospital Research Institute This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials essential to the performance of… $54,800
Swedish Health Services Site Swedish Health Services This site will employ their best efforts in the performance of the work requirements listed below and provide data and materials… $54,800
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Quick answers

Who received award U01DK138901?

U01DK138901 was awarded to The Trustees Of The University Of Pennsylvania by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on July 1, 2024.

How much is award U01DK138901 worth?

$7,655,738 has been obligated on U01DK138901.

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