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

Last updated: October 31, 2025
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Sample Collection

Clinical Study ID

NCT04113733
191738
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 cancerscreening or patients with a diagnosis of Crohn's disease (CD) confirmed byendoscopy or radiology assessment undergoing colonoscopy for clinical care

Exclusion

Exclusion criteria:

  • Pregnancy

  • Coagulopathy or bleeding disorder

  • Renal or hepatic impairment

  • History of organ transplantation

Study Design

Total Participants: 178
Treatment Group(s): 1
Primary Treatment: Sample Collection
Phase:
Study Start date:
December 17, 2019
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

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