Severe Crohn's DieaseNCT04135482
CD Patients Immune Status Evaluation
An observational study of Severe Crohn's Diease, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Using single cell sequencing method to evaluate and compare the immune status of patients with severe CD. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Crohn's Diease
- What is being tested?
- colonic tissue biopsy
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2019to 31 Jul 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients were diagnosed as severe CD based on clinical, laboratory, endoscopic changes and imging.
Inclusion Criteria: 1, Patients with severe CD（CDAI>16,SES-CD>19） 2, Patients have no previous any drug therapy targeting CD or just received treatment of 5-ASA - Exclusion Criteria: 1, patients have previous treatment of prednisone, immunosuppressive agents such as azathioprine and biologic agents such as infliximab 2, patients were diagnozed as mild-moderate CD 3, patients have other immune disordered diseases such as SLE, PBC, AIH, PSC, sjogren syndrome, ulcerative colitis, and so on.
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Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, 310003
About this study
Official title: Evaluating the Immune Status of Patients With Severe Crohn's Disease Using Single Cell Sequencing
Using single cell sequencing method to evaluate and compare the immune status of patients with severe CD.
- Conditions
- Severe Crohn's Diease
- Being tested
- colonic tissue biopsy
- Keywords
- singcel cell sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonic tissue biopsyOther
colonic tissue biospy of patients with severe crohn's disease using colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| CD | patients with severe crohn's disease Receives: Other: colonic tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
single cell analysis of the colonic tissue of patients with severe crohn's disease
single cell analysis of the colonic tissue of patients with severe crohn's disease: inflammed and non-inflammed area from right colon or the terminal ileum
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start21 Oct 2019
- Primary completion15 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Crohn's DieaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135482
- Sponsor's protocol ID
- ZJU-JX-CD1
- Status last verified
- Oct 2019
- First submitted
- 20 Oct 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Immune Status of Patients With Severe Crohn's Disease Using Single Cell Sequencing
- ClinicalTrials.gov ID
- NCT04135482
- Acronym / sponsor ID
- ZJU-JX-CD1
- Conditions
- Severe Crohn's Diease
- Keywords
- singcel cell sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 22 Oct 2019 (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.
Using single cell sequencing method to evaluate and compare the immune status of patients with severe CD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD | – | Other: colonic tissue biopsypatients with severe crohn's disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were diagnosed as severe CD based on clinical, laboratory, endoscopic changes and imging.
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 |
|---|---|---|
| colonic tissue biopsycolonic tissue biospy of patients with severe crohn's disease using colonoscopy | Other | CD |
Primary outcome
single cell analysis of the colonic tissue of patients with severe crohn's disease
Time frame: 1 year
single cell analysis of the colonic tissue of patients with severe crohn's disease: inflammed and non-inflammed area from right colon or the terminal ileum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Severe Crohn's Diease, run by First Affiliated Hospital of Zhejiang University 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?
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: finished, as of the sponsor's last update on 21 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
single cell analysis of the colonic tissue of patients with severe crohn's disease (time frame: 1 year). 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 21 Feb 2023.