Prospective StudyNCT03698812
A Multicenter Prospective Cohort Study on the Clinical Prognosis of Ulcerative Colitis
An observational study of Prospective Study and Ulcerative Colitis in Remission, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Mucosal healing or histological remission is an important target for the treatment of inflammatory bowel disease. In this study, patients with mucosal healing are defined as a control group, observing their clinical outcomes for 3 years, and describing the recurrence rate. Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prospective Study, Ulcerative Colitis in Remission
- What is being tested?
- Colonoscope
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Sep 2021
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The project includes 320 cases from 4 Hospital. The EG and CG has 160 cases. Nanfang Hospital of southern medical university:230 cases(EG115,CG115) Zhujiang Hospital of southern medical university:30 cases(EG15,CG15) Third affiliated hospital of southern medical university： 30 cases(EG15,CG15) First Hospital Affiliated to Shantou University：30 cases(EG15,CG15)
Who may be able to join
- sign informed consent before proceeding with any specific procedure.
- ages:14-75
- subjects were diagnosed with ulcerative colitis in written form. (written diagnosis should include at least one histopathological change).
- mucosal healing or histological remission has been achieved after medical treatment.
- histological assessment is performed by 2 pathologists independently, and endoscopy have been independently evaluated by two endoscopic doctors.
- prospective cohort study (3) definition of endoscopic mucosal healing: Baron score<=1 and Mayo score<=1 (4) definition of histological remission: Truelove/ Richards=1 and Geboes score<3.0 (5) sampling methods: the terminal ileum, the ascending colon, the transverse colon, the descending colon, the sigmoid colon, and the rectum, the six parts were randomly taken specimen (at least 2 tissues each).
- data integrity: the research data include: 1) enteroscopy; 2) laboratory examination indicators: blood routine, erythrocyte sedimentation rate, C reaction protein, liver function, renal function, fecal calprotectin, 3) serum concentration of infliximab, antibody to infliximab.
- subjects were treated with the following treatment Mesalazine, glucocorticoid, immunosuppressive agent (azathioprine or thalidomide), biologics (infliximab) 7. subjects have the ability to answer the questionnaire
Who cannot join
- The diagnosis is unclear
- Subjects with history of colectomy
- Subjects with history of cancerogenesis
- Subjects with severe liver disease, defined as child-pugh Grade B or Grade C
- Subjects with severe renal disease, defined as Estimated glomerular filtration rate<30
- major cardiovascular events, such as stroke, myocardial infarction, or unstable angina, occurred within 3 months before enrollment.
Show all 9Show fewer
- Subjects during pregnancy.
- alcohol or drug abuse
- poor compliance 10 Planners and investors
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, sunwingwxy@163.com
Xinying Wang, MD, 13726754880, sunwingwxy@163.com
About this study
Official title: A Multicenter Prospective Follow-up Study on the Effect of Histological Remission on the Clinical Prognosis of Ulcerative Colitis
Mucosal healing or histological remission is an important target for the treatment of inflammatory bowel disease. In this study, patients with mucosal healing are defined as a control group, observing their clinical outcomes for 3 years, and describing the recurrence rate. The secondary objective is to study the operative rate, glucocorticoid utilization rate, treatment escalation rate, hospitalization rate and incidence of related complications.
Read the detailed description
Assess the health condition of patients for 1year, 2year,3year and analyze outcomes and complications.
- Conditions
- Prospective Study, Ulcerative Colitis in Remission
- Being tested
- Colonoscope
- Keywords
- Ulcerative Colitis, Mucosal Healing, Histological Remission, Prospective Study
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopeCombination product
take off specimen
| Study group | Role | What they receive |
|---|---|---|
| CTL group | control group Receives: Combination Product: Colonoscope | |
| EXP group | Colonoscope Receives: Combination Product: Colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse rate
CAI ≥5 or necessity for additional treatment
Measured: 1year
Secondary outcomes (4)
surgery rate
disease progress requiring surgery
Measured: 1year，2year，3year
Rehospitalization rate
observation
Measured: 1year，2year，3year
requirement for escalation of drugs
observation
Measured: 1year，2year，3year
complication rate
toxic megacolon，perforation，carcinogenesis
Measured: 1year，2year，3year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jan 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prospective StudyStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xinying wang, Nanfang Hospital, Southern Medical University
- Investigators
- Xinying Wang, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698812
- Sponsor's protocol ID
- LC2016PY007
- Status last verified
- Oct 2018
- First submitted
- 30 Sep 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 1. ages:14-75 2. subjects were diagnosed with ulcerative colitis in written form. (written diagnosis should include at least one histopathological change). 3. mucosal healing or histological remission has been achieved after medical treatment. 4. data integrity
Publications
D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.
PubMed 17258735
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Follow-up Study on the Effect of Histological Remission on the Clinical Prognosis of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03698812
- Acronym / sponsor ID
- LC2016PY007
- Conditions
- Prospective Study, Ulcerative Colitis in Remission
- Keywords
- Ulcerative Colitis, Mucosal Healing, Histological Remission, Prospective Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 9 Oct 2018 (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.
Mucosal healing or histological remission is an important target for the treatment of inflammatory bowel disease. In this study, patients with mucosal healing are defined as a control group, observing their clinical outcomes for 3 years, and describing the recurrence rate. The secondary objective is to study the operative rate, glucocorticoid utilization rate, treatment escalation rate, hospitalization rate and incidence of related complications.
Detailed description
Assess the health condition of patients for 1year, 2year,3year and analyze outcomes and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTL group | – | Combination Product: Colonoscopecontrol group |
| EXP group | – | Combination Product: ColonoscopeColonoscope |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The project includes 320 cases from 4 Hospital. The EG and CG has 160 cases. Nanfang Hospital of southern medical university:230 cases(EG115,CG115) Zhujiang Hospital of southern medical university:30 cases(EG15,CG15) Third affiliated hospital of southern medical university： 30 cases(EG15,CG15) First Hospital Affiliated to Shantou University：30 cases(EG15,CG15)
Key inclusion criteria (8 listed)
- sign informed consent before proceeding with any specific procedure.
- ages:14-75
- subjects were diagnosed with ulcerative colitis in written form. (written diagnosis should include at least one histopathological change).
- mucosal healing or histological remission has been achieved after medical treatment.
- data integrity: the research data include: 1) enteroscopy; 2) laboratory examination indicators: blood routine, erythrocyte sedimentation rate, C reaction protein, liver function, renal function, fecal calprotectin, 3) serum concentration of infliximab, antibody to infliximab.
Key exclusion criteria (9 listed)
- The diagnosis is unclear
- Subjects with history of colectomy
- Subjects with history of cancerogenesis
- Subjects with severe liver disease, defined as child-pugh Grade B or Grade C
- Subjects with severe renal disease, defined as Estimated glomerular filtration rate<30
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 |
|---|---|---|
| Colonoscopetake off specimen | Combination product | CTL group, EXP group |
Primary outcome
relapse rate
Time frame: 1year
CAI ≥5 or necessity for additional treatment
4 secondary outcomes
surgery rate
Time frame: 1year，2year，3year
Rehospitalization rate
Time frame: 1year，2year，3year
requirement for escalation of drugs
Time frame: 1year，2year，3year
complication rate
Time frame: 1year，2year，3year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Results publication: PubMed 17258735D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.
- Individual participant dataSharing planned: Yes. 1. ages:14-75 2. subjects were diagnosed with ulcerative colitis in written form. (written diagnosis should include at least one histopathological change). 3. mucosal healing or histological remission has been achieved after medical treatment. 4. data integrity
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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.
Xinying Wang principal investigator
Nanfang Hospital, Southern Medical University
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 Prospective Study and Ulcerative Colitis in Remission, run by Nanfang Hospital, Southern Medical 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?
The sponsor lists 8 inclusion and 9 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 17 Oct 2018. 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?
Contact Xinying Wang, MD (13726754880, sunwingwxy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse rate (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03698812, which also lists 1 linked publication.
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 17 Oct 2018.