Crohn DiseaseNCT04135027
Study of Factors and Mechanisms Influencing the Effects of Treatments in Crohn's Disease
An observational study of Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites in China.
Trial summary
The course of Crohn's disease (CD) varies considerably between patients, but reliable prognostic markers are not available in clinical practice. Even though several parameters have been associated with prognosis in CD-including clinical features, serology and genetic variants-none are sufficient to guide therapy in… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- How many people
- 500 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jul 2019to 30 Dec 2022
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients aged 14-80 years old, newly diagnosed or previously diagnosed of Crohn's disease according to 2010 WGO criteria for Crohn's disease were recruited from a specialist IBD clinic.
Who may be able to join
- Newly diagnosed or Previously diagnosed of Crohn's disease according to 2010 WGO criteria for Crohn's disease
- Aged 14-80 years old.
Who cannot join
- History of malignancy
- Pregnant/breastfeeding at screening
- Other serious medical or psychiatric illness.
- Unable to comply with protocol requirements
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
The Chongqing Hospital of the University of Chinese Academy of Sciences (Chongqing People's Hospital)
Chongqing, Chongqing Municipality
Hong Guo
- Recruiting
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, 310000
Wen Hu, MD, huwen_mc@163.com
- Recruiting
Nanjing Drum Tower Hospital (Nanjing Gulou Yi Yuan), the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Xiaoqi Zhang
- Recruiting
Huadong Hospital affiliated to Fudan University
Shanghai
Yuanwen Chen
About this study
Official title: Study of Factors and Mechanisms Influencing the Effects of Treatments in Crohn's Disease Patients (a Prospective, Observational Cohort Designed for Precise Evaluation, Personalized RIsk Stratification and Targeted Treatment (PRIST Cohort))
The course of Crohn's disease (CD) varies considerably between patients, but reliable prognostic markers are not available in clinical practice. Even though several parameters have been associated with prognosis in CD-including clinical features, serology and genetic variants-none are sufficient to guide therapy in clinical practice. Trying to find out the mechanisms influencing the effectiveness of treatments and develop a personalized therapy is an urgent problem in the era of biologics as the investigators now have a growing armamentarium of IBD therapies. Several scientists found that the levels of T cells subsets ratio and inflammation cytokines were significantly increased in the intestinal mucosa and serum in active IBD patients, whereas mucosal innate lymph cells had specific effects in inflammation. However the studies about the differences of lymph cell levels between subgroups of IBD patients and their relationships with effectiveness of treatments are relatively rare. Based on above, the investigators plan to recruit patients diagnosed and suspicious of Crohn's disease and a group of diseases in differential diagnosis of CD to keep track of their disease characteristics, therapy and response, collect their blood sample at specific points of time, to investigate the mechanisms of heterogeneity of therapy effectiveness.
- Conditions
- Crohn Disease
- Being tested
- no interventions
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
no interventions
| Study group | Role | What they receive |
|---|---|---|
| CD group | no interventions Receives: Other: no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first treatment escalation
time to first treatment escalation
Measured: 6 months to 1 year
bowel surgery
time to receive bowel surgery after diagnosis
Measured: 1 month to 1 year
Secondary outcomes (1)
side effects of medications
side effects of medications including infection and malignancy etc.
Measured: 1 month to 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 start1 Jul 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135027
- Sponsor's protocol ID
- IR2019001055
- Status last verified
- Jan 2022
- First submitted
- 2 Oct 2019
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Factors and Mechanisms Influencing the Effects of Treatments in Crohn's Disease Patients (a Prospective, Observational Cohort Designed for Precise Evaluation, Personalized RIsk Stratification and Targeted Treatment (PRIST Cohort))
- ClinicalTrials.gov ID
- NCT04135027
- Acronym / sponsor ID
- IR2019001055
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- 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.
The course of Crohn's disease (CD) varies considerably between patients, but reliable prognostic markers are not available in clinical practice. Even though several parameters have been associated with prognosis in CD-including clinical features, serology and genetic variants-none are sufficient to guide therapy in clinical practice. Trying to find out the mechanisms influencing the effectiveness of treatments and develop a personalized therapy is an urgent problem in the era of biologics as the investigators now have a growing armamentarium of IBD therapies. Several scientists found that the levels of T cells subsets ratio and inflammation cytokines were significantly increased in the intestinal mucosa and serum in active IBD patients, whereas mucosal innate lymph cells had specific effects in inflammation. However the studies about the differences of lymph cell levels between subgroups of IBD patients and their relationships with effectiveness of treatments are relatively rare. Based on above, the investigators plan to recruit patients diagnosed and suspicious of Crohn's disease and a group of diseases in differential diagnosis of CD to keep track of their disease characteristics, therapy and response, collect their blood sample at specific points of time, to investigate the mechanisms of heterogeneity of therapy effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD group | – | Other: no interventionsno interventions |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 14-80 years old, newly diagnosed or previously diagnosed of Crohn's disease according to 2010 WGO criteria for Crohn's disease were recruited from a specialist IBD clinic.
Key inclusion criteria (2 listed)
- Newly diagnosed or Previously diagnosed of Crohn's disease according to 2010 WGO criteria for Crohn's disease
- Aged 14-80 years old.
Key exclusion criteria (4 listed)
- History of malignancy
- Pregnant/breastfeeding at screening
- Other serious medical or psychiatric illness.
- Unable to comply with protocol requirements
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 |
|---|---|---|
| no interventionsno interventions | Other | CD group |
Primary outcome
time to first treatment escalation
Time frame: 6 months to 1 year
time to first treatment escalation
bowel surgery
Time frame: 1 month to 1 year
time to receive bowel surgery after diagnosis
1 secondary outcome
side effects of medications
Time frame: 1 month to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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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.
4 sites 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, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites 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 2 inclusion and 4 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 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Yan Chen, MD (+8613757118653, 1254499542@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first treatment escalation (time frame: 6 months to 1 year). The study lists 2 primary outcomes in all. 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 2 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.