F12-119: PREDICT

Overview

Status: Recruiting
Keywords: crohns disease , crohns
IRB Number: 00066498
Specialty: Gastroenterology
Sub Specialties:

Brief Summary

The purpose of this study is to evaluate these indices scores in a broader population of Crohn's disease, not limited by disease severity or concomitant therapy. Moreover, we plan to explore additional variables which may improve these indices scores in a heterogenic Crohn's disease population.
 
The difference between this study and previous studies is that this study will not be administering study medication nor assessing treatment effect. This study is considered an observational, non-drug interventional study.
 
The primary objective of this study is to evaluate three new indices scores for mucosal ulceration utilizing laboratory data and questionnaires. These indices scores will be compared to endoscopic assessments of mucosal ulceration status in adult subjects with Crohn's disease.
 
The secondary objective is to explore the potential to improve these indices

Principal Investigator: John Valentine
Department: Gastroenterology
Co Investigator:

Contact Information

Name:Andrew Grandemange
Phone: 8015879092
Email: andrew.grandemange@hsc.utah.edu

Inclusion Criteria

A subject will be eligible for study participation if he or she meets the following criteria:
 
1. Male or female between 18 and 75 years of age, inclusive.
 
2. Confirmed diagnosis of Crohn's disease for at least 3 months prior to signing the informed consent (i.e., diagnosis confirmed by endoscopy, radiologic evaluation, histology, or surgical pathology)
 
3. PI has determined the need for a clinically indicated endoscopy. Reasons for a clinically indicated endoscopy include but are not limited to further assessment of active symptoms, surveillance for colorectal dysplasia and cancer, evaluation for post-operative recurrence following surgical resection, and evaluation for mucosal healing following a change in therapy.
 
4. Must voluntarily sign and date each informed consent, approved by an Independent Institutional
Review Board (IRB), prior to the initiation of any study-specific procedures.

Exclusion Criteria

A subject will not be eligible for study participation if he or she meets any of the following criteria:
 
1. Subjects who are unable and/or unwilling to sign informed consent.
 
2. Subjects with a currently present ostomy or an ileoanal pouch.
 
3. Subjects with symptomatic bowel strictures/stenosis.
 
4. Subjects with extensive small bowel resection (as determined by the investigator), or short bowel syndrome, or who are planning any bowel resection at any time point while enrolled in this study.
 
5. Subjects who are currently receiving total parenteral nutrition (TPN).