Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients

NCT03566407 | Terminated

• 1 other identifier: 17IBD01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the relationship between noninvasive biomarkers (patient serological markers and metagenomic analysis of stool) and disease status as determined by colonoscopy and by clinical symptoms in patients with Crohn's disease, and to evaluate whether changes in the biomarker levels over time correlate to changes in the state of patients' disease.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (2)

• Assess disease status biomarkers against colonoscopy

  The primary endpoint for assessing clinical validity of candidate biomarker will be correlation to the degree of mucosal healing as determined by colonoscopy scored by the Simple Endoscopic Score for Crohn's Disease (SES-CD). - A scale that via colonoscopy of Crohn's disease patients measures: 1. Presence and size of ulcers 2. Extent of ulcerated surface 3. Extent of affected surface and 4. Presence and type of intestinal narrowings. Scale goes from 0 to 56 with a higher score indicating greater severity of disease.

  6 months

• Assess disease status biomarkers against colonoscopy

  The primary endpoint for assessing clinical validity of candidate biomarker will also be correlated to the degree of mucosal healing as determined by colonoscopy scored by the Crohn's Disease Endoscopic Index of Severity (CDEIS). A scale that via colonoscopy of Crohn's disease patient's measures: 1. Deep Ulcerations 2. Superficial Ulcerations 3. Surface involved by disease and 4.Surface involved by ulcerations. Scale goes from 0 to 44 with a higher score indicating greater severity of disease.

  6 months

Secondary Outcomes (4)

• Assess bacterial markers in stool against colonoscopy scoring system Simple Endoscopic Score for Crohn's Disease (SES-CD)

  6 months

• Assess bacterial markers in stool against colonoscopy scoring system Crohn's Disease Endoscopic Index of Severity (CDEIS)

  6 months

• Assess bacterial markers in stool against disease symptomology scored by Harvey Bradshaw Index (HBI) for clinical evaluation

  6 months

• Assess bacterial markers in stool against disease symptomology scored by Crohn's Disease Activity Index (CDAI) for clinical evaluation

  6 months

Study Arms (1)

Single Group

OTHER

This is a prospective, longitudinal descriptive study of subjects with diagnosed Crohn's disease. Blood samples for measurement of protein biomarkers (serology), fresh whole blood for detection of gene polymorphisms, and stool samples for detection and assessment of microbiome and host DNA will be collected, and colonoscopy will be performed.

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

Colonoscopy will be required for all subjects at 6 months - Visit 3.

Single Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females with CD who are 18 years of age or older on the date of obtaining informed consent and are undergoing a colonoscopy at the study site.
• The patient must have a confirmed diagnosis of CD based on results a complete medical evaluation and the assessment by a physician specialized in inflammatory bowel disease.

You may not qualify if:

• All patients must have a colonoscopic examination performed preferably on the same day as blood specimen is drawn, or blood may be drawn up to one week prior to colonoscopy. Stool specimen will be collected prior to the beginning of bowel prep for the colonoscopy, up to 10 days prior to bowel prep.
• Understand the procedures and requirements of the study by providing written informed consent including consent and authorization for protected health information disclosure.
• Extensive small bowel resection or short bowel syndrome.
• Surgery for CD within the 6 months previous to enrollment.
• Receipt of any blood products within 3 months prior to study entry.
• Known pregnancy or breast feeding within 3 months of specimen collection.
• Recent history of viral or bacterial gastroenteritis including Clostridium difficile infection \< 4 weeks prior to the blood draw
• Concurrent diagnosis of another currently active erosive GI mucosal disease such as erosive esophagitis, gastric or duodenal ulcer, celiac sprue, diverticulitis, etc.
• History of intestinal or colorectal cancer, of active autoimmune diseases, or of other chronic uncontrolled systemic disorders
• History of bowel prep within the past 3 months.
• History of alcohol or substance abuse.
• History of prior colectomy or stricturing disease that could limit colonoscopy examination of small bowel mucosa.
• Current ostomy or ileoanal pouch.
• Current or previous (of less than 4 weeks prior) participation in in a clinical trial for an investigational drug.

Sponsors & Collaborators

• Prometheus Laboratories: lead

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

Location

Ventura Clinical Trials, LLC.

Ventura, California, 93003, United States

Location

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

Atlanta Gastroenterology Associates, LLC

Atlanta, Georgia, 30309, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Clinical Development and Medical Affairs

  Prometheus Laboratories

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All study subjects will undergo a protocol required 6 month colonoscopy

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: June 25, 2018
• Study Start: May 4, 2018
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-06

Locations

US (5)