Clinical trial NCT03698812: A Multicenter Prospective Cohort Study on the Clinical Prognosis of Ulcerative Colitis
Official title: A Multicenter Prospective Follow-up Study on the Effect of Histological Remission on the Clinical Prognosis of Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prospective Study
Ulcerative Colitis in Remission
Keywords: Ulcerative Colitis
Mucosal Healing
Histological Remission
Prospective Study
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 9
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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)

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

  1. histological assessment is performed by 2 pathologists independently, and endoscopy have been independently evaluated by two endoscopic doctors.
  2. 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

Exclusion Criteria:

* 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.
* Subjects during pregnancy.
* alcohol or drug abuse
* poor compliance 10 Planners and investors

Primary outcomes:
measure: relapse rate
timeFrame: 1year
Secondary outcomes:
measure: surgery rate
timeFrame: 1year，2year，3year
measure: Rehospitalization rate
timeFrame: 1year，2year，3year
measure: requirement for escalation of drugs
timeFrame: 1year，2year，3year
measure: complication rate
timeFrame: 1year，2year，3year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Xinying Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.