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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04113733
• Other study ID #: 191738
• Status: Enrolling by invitation
• Start date: December 17, 2019
• Est. completion date: February 2027

Study information

• Verified date: October 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 190
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• Sample Collection
Tissue biopsies will be performed at the time of colonoscopy along with blood and stool sample collection.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in cellular composition (i.e., percentage of cell types) between Crohn's disease and control patients as assessed by single-cell RNA sequencing analysis, RNA-fluorescence in situ hybridization, and multiplex immunofluorescence.		36 months