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NCT04113733

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

StatusActive, Not Recruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved at least 8 months later.

See at-risk trials from Vanderbilt University Medical Center

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Record History

All 10 versions: 6 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Feb 2027 to Nov 2027
    • Eligibility criteria expanded, about 7 words
    • Primary endpoints: details revised at 1 of 1 entry
  2. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 190 to confirmed 178
    v8
  3. Primary and study completion dates: Dec 2022 to Feb 2027
    • Enrollment target: 160 to 190
    v6
  4. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Primary and study completion dates: Nov 2022 to Dec 2022
    • Start date changed from estimate of Jan 2020 to Dec 17, 2019
    • Site contact updated
    v3
  5. Start date: Nov 2019 to Jan 2020
    • Site contact updated
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

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.
Timeframe: 36 months

Arms and interventions

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.

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.

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.

Other: Sample Collection

Sites

1 site in 1 country

  • Vanderbilt University Medical CenterNashville, Tennessee, United States