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Status unknownNCT03272152Updated Sep 5, 2017

Comprehensive DNA Methylation Profiling in Crohn's Disease

An observational study in Crohn Disease, Methylation and Illumina Human Methylation 850k BeadChip, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-05.

Sponsored by Jinling Hospital, China · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
14
Ages
18 Years to 60 Years
Sex
Male
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Study summary

Previous studies have indicated that abnormal DNA methylation frequently occurs in the mucosa in Crohn's disease. Comprehensive DNA methylation profiling of the inflamed and non-inflamed ileal mucosa of patients with Crohn's disease was performed. Genome-wide DNA methylation was determined using the Illumina HumanMethylation 850k BeadChip.

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Conditions studied

  • Crohn Disease
  • Methylation
  • Illumina Human Methylation 850k BeadChip

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with active Crohn's disease who underwent colonoscopy at Jinling Hospital

Inclusion criteria

  • Active Crohn's disease(CDAI score≥ 150)

Exclusion criteria

Exclusion Criteria:

  • No ileal lesions
  • Under treatment of immunomodulators, biologic agents or steroids
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
14 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Inflamed CD group

    Inflamed ileal mucosa was obtained from inflammed lesions of active CD patients

    Genetic: Genome-wide DNA methylation

  • Non-inflamed CD group

    Non-inflamed ileal mucosa was obtained from normal sites of active CD patients

    Genetic: Genome-wide DNA methylation

  • Control group

    Control ileal mucosa was obtained from healthy patients

    Genetic: Genome-wide DNA methylation

Interventions

  • GeneticGenome-wide DNA methylation

    Genome-wide DNA methylation was determined using the Infinium Human Methylation 850K BeadChip.

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What researchers measure

Primary outcomes

  1. Intestinal inflammation under colonoscopy

    Intestinal ulcer or enteritisis observed under colonoscopy

    Time frame: Jan 2017 to Sep 2017

Secondary outcomes

  1. CDAI

    Crohns Disease Activity Index is measured.

    Time frame: Jan 2017 to Sep 2017

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Study locations

1 of 1 sites recruiting
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Registry details

Key details

Study ID
NCT03272152
Lead sponsor
Jinling Hospital, China
Responsible party
Jianan Ren (Director of General Surgery Institute, Jinling Hospital, China) — Principal investigator
First posted
Sep 5, 2017
Start date
Jan 1, 2017
Primary completion
Sep 30, 2017 (estimated)
Completion
Sep 30, 2017 (estimated)
Last update
Sep 5, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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