Crohn DiseaseNCT03272152
Comprehensive DNA Methylation Profiling in Crohn's Disease
An observational study of Crohn Disease and Methylation, run by Jinling Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Methylation, Illumina Human Methylation 850k BeadChip
- What is being tested?
- Genome-wide DNA methylation
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Sep 2017
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Patients with active Crohn's disease who underwent colonoscopy at Jinling Hospital
Who may be able to join
- Active Crohn's disease(CDAI score≥ 150)
Who cannot join
- No ileal lesions
- Under treatment of immunomodulators, biologic agents or steroids
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210002
Jianan Ren, MD, PhD, jiananr@gmail.com
Yuan Li, MD, liyuan9006@gmail.com
About this study
Official title: Comprehensive DNA Methylation Profiling of Inflammatory and Non-Inflammatory Mucosa in Crohn's Disease
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.
- Being tested
- Genome-wide DNA methylation
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genome-wide DNA methylationGenetic
Genome-wide DNA methylation was determined using the Infinium Human Methylation 850K BeadChip.
| Study group | Role | What they receive |
|---|---|---|
| Inflamed CD group | Inflamed ileal mucosa was obtained from inflammed lesions of active CD patients Receives: Genetic: Genome-wide DNA methylation | |
| Non-inflamed CD group | Non-inflamed ileal mucosa was obtained from normal sites of active CD patients Receives: Genetic: Genome-wide DNA methylation | |
| Control group | Control ileal mucosa was obtained from healthy patients Receives: Genetic: Genome-wide DNA methylation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal inflammation under colonoscopy
Intestinal ulcer or enteritisis observed under colonoscopy
Measured: Jan 2017 to Sep 2017
Secondary outcomes (1)
CDAI
Crohns Disease Activity Index is measured.
Measured: Jan 2017 to Sep 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Jan 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion30 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Ren, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272152
- Sponsor's protocol ID
- 20170808
- Status last verified
- Aug 2017
- First submitted
- 31 Aug 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive DNA Methylation Profiling of Inflammatory and Non-Inflammatory Mucosa in Crohn's Disease
- ClinicalTrials.gov ID
- NCT03272152
- Acronym / sponsor ID
- 20170808
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 30 Sep 2017 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inflamed CD group | – | Genetic: Genome-wide DNA methylationInflamed ileal mucosa was obtained from inflammed lesions of active CD patients |
| Non-inflamed CD group | – | Genetic: Genome-wide DNA methylationNon-inflamed ileal mucosa was obtained from normal sites of active CD patients |
| Control group | – | Genetic: Genome-wide DNA methylationControl ileal mucosa was obtained from healthy patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with active Crohn's disease who underwent colonoscopy at Jinling Hospital
Key inclusion criteria (1 listed)
- Active Crohn's disease(CDAI score≥ 150)
Key exclusion criteria (2 listed)
- No ileal lesions
- Under treatment of immunomodulators, biologic agents or steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genome-wide DNA methylationGenome-wide DNA methylation was determined using the Infinium Human Methylation 850K BeadChip. | Genetic | Control group, Inflamed CD group, Non-inflamed CD group |
Primary outcome
Intestinal inflammation under colonoscopy
Time frame: Jan 2017 to Sep 2017
Intestinal ulcer or enteritisis observed under colonoscopy
1 secondary outcome
CDAI
Time frame: Jan 2017 to Sep 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Methylation, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal inflammation under colonoscopy (time frame: Jan 2017 to Sep 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.