NCT04113733Active, not recruiting
Combinatorial Single Cell Strategies for a Crohn's Disease Gut Cell Atlas
Source: ClinicalTrials.gov · Last updated 4 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 178 (actual)
- First submitted
- 27 Sept 2019
- Start date
- 17 Dec 2019
- Primary completion date
- Feb 2027
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Crohn's disease
- NCT number
- NCT04113733
What you commit to
- Study type: Observational
- Participants enrolled: 178
- From 17 Dec 2019 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Coagulopathy or bleeding disorder
- Renal or hepatic impairment
- History of organ transplantation
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.