Combinatorial Single Cell Strategies for a Crohn's Disease Gut Cell Atlas

NCT ID: NCT04113733

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2027-02-28

Brief Summary

Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and ulcerative colitis, affects more than 1.6 million people in the United States alone. Despite current therapies, remission only occurs in approximately half of patients. The goal of study is to map single-cell spatial relationships across the spectrum of ileum/ascending colon from healthy control patients to uninvolved/quiescent and involved/active CD patients and assess for relationships between single-cell data and patient clinical data.

The investigators will utilize endoscopic mucosal biopsies and surgical resection specimens with rapid transfer of fresh tissue to the single-cell preparation for RNA-sequencing and use of tissues for RNA-fluorescence in situ hybridization and multiplex immunofluorescence. Along with machine learning image analysis and bioinformatics, this will generate a robust/detailed single-cell gut cell atlas (GCA) of ileo-colonic CD at all disease activities versus normal tissues. The study will also compare the results of endoscopic mucosal biopsies to those obtained from full thickness surgical specimens by utilizing the Cooperative Human Tissue Network (CHTN).

The investigators anticipate the GCA data will provide new insights into disease pathogenesis, leading to new therapeutic targets.

Conditions

Crohn Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Crohn's Disease

This group consists of patients with a diagnosis of Crohn's disease undergoing colonoscopy for clinical care. Samples including tissue biopsy, blood and stool will be collected one time. In addition, patient information that may include questionnaires and medical record review will be collected.

Sample Collection

Intervention Type: OTHER

Tissue biopsies will be performed at the time of colonoscopy along with blood and stool sample collection.

Control

This group will include patients undergoing screening colonoscopy as part of standard of care. Samples including tissue biopsy, blood and stool will be collected one time. In addition, patient information that may include questionnaires and medical record review will be collected.

Sample Collection

Intervention Type: OTHER

Tissue biopsies will be performed at the time of colonoscopy along with blood and stool sample collection.

Cooperative Human Tissue Network

This group will consist of non-IBD patients and Crohn's disease patients participating in the Cooperative Human Tissue Network (CHTN). The CHTN will be utilized to obtain surgical specimens from these patients. The patients will be screened and consented via the CHTN protocol. No additional samples in the form of blood or stool will be collected. Associated clinical data will be collected through medical record review.

No interventions assigned to this group

Interventions

Sample Collection

Tissue biopsies will be performed at the time of colonoscopy along with blood and stool sample collection.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Provision of consent form
• Male or female greater than or equal to 18 years old
• Healthy volunteers without IBD undergoing colonoscopy for colorectal cancer screening or patients with a diagnosis of Crohn's disease (CD) confirmed by endoscopy or radiology assessment undergoing colonoscopy for clinical care

Exclusion Criteria

• Pregnancy
• Coagulopathy or bleeding disorder
• Renal or hepatic impairment
• History of organ transplantation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lori Coburn

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori A Coburn, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Keith T Wilson, MD

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

191738

Identifier Type: -

Identifier Source: org_study_id