NCT03272152

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

September 5, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

August 31, 2017

Last Update Submit

August 31, 2017

Conditions

Crohn DiseaseMethylationIllumina Human Methylation 850k BeadChip

Outcome Measures

Primary Outcomes (1)

  • Intestinal inflammation under colonoscopy

    Intestinal ulcer or enteritisis observed under colonoscopy

    Jan 2017 to Sep 2017

Secondary Outcomes (1)

  • CDAI

    Jan 2017 to Sep 2017

Study Arms (3)

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

Genome-wide DNA methylationGENETIC

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

Control groupInflamed CD groupNon-inflamed CD group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

inflamed and non-inflamed ileal mucosa of patients with Crohn's disease and normal ileal mucosa of healthy controls

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of General Surgery Institute

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 5, 2017

Study Start

January 1, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

September 5, 2017

Record last verified: 2017-08

Locations

CN(1)