Histopathologic definition11/5/2023 ![]() Validate an objective machine learning methodology for scoring of mucosal healing that can be used in clinical trials, regulatory approvals, and clinical practice.Standardize the histopathologic measurement of mucosal healing that correlates with better clinical response and long-term patient outcomes.Establish the optimum number and locations of biopsies required to determine histological inflammation in UC. ![]() A primary site of infection must be identified and an NHSN site specific infection definition must be met. This proposal will build a unique dataset to define the best practice for measuring mucosal healing by leveraging existing datasets from at least 3 organizations to: What is meant by patient has an abscess or other evidence of infection on gross anatomic or histopathologic exam. The final results of this project will help generate a common protocol and white paper that drives industry consensus and will be submitted to FDA in order to influence regulatory guidance for companies conducting UC clinical trials in the future. This measurement must demonstrate clear prognostic value for predicting long-term patient outcomes. This project aims to address this gap by establishing a common methodology for a histologic measurement of mucosal healing in treatment of UC. The lack of standardized measurement of mucosal healing constitutes a major challenge for UC drug development and negatively impacts treatment options for patients with this serious, chronic, inflammatory bowel disease. Standardized assessment of histologic disease activity in UC clinical trials is challenging for many reasons, including variability in how studies collect mucosal biopsies (e.g., the optimum number and location), lack of fully validated histology scoring systems, and absence of standard definitions of histologic improvement and remission. However, there is no community consensus on how to define mucosal healing and, even with a standard definition, the field would lack standardized protocols for measuring this treatment target endpoint. In a 2016 draft guidance to industry, FDA encouraged incorporating histologic evaluation in ulcerative colitis (UC) clinical trials to reliably conclude “mucosal healing” or histological remission as a treatment goal. The Deeda Blair Research Initiative for Disorders of the Brain.In contrast, cytopathology examines free cells or tissue micro-fragments (as 'cell blocks'). Trailblazer Prize for Clinician-Scientists Specifically, in clinical medicine, histopathology refers to the examination of a biopsy or surgical specimen by a pathologist, after the specimen has been processed and histological sections have been placed onto glass slides.Partnership For Accelerating Cancer Therapies (PACT). ![]()
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