A Multicenter Prospective Cohort Study on the Clinical Prognosis of Ulcerative Colitis

Prospective Study Clinical Trial

Official title:

A Multicenter Prospective Follow-up Study on the Effect of Histological Remission on the Clinical Prognosis of Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03698812
• Other study ID #: LC2016PY007
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xinying Wang, MD
• Phone: 13726754880
• Email: sunwingwxy[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The secondary objective is to study the operative rate, glucocorticoid utilization rate, treatment escalation rate, hospitalization rate and incidence of related complications.

Description:

Assess the health condition of patients for 1year, 2year,3year and analyze outcomes and complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Prospective Study
• Ulcer
• Ulcerative Colitis in Remission

Intervention

Combination Product:
• Colonoscope
take off specimen

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lémann M, Marteau P, Rutgeerts P, Schölmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse rate	CAI =5 or necessity for additional treatment	1year
Secondary	surgery rate	disease progress requiring surgery	1year,2year,3year
Secondary	Rehospitalization rate	observation	1year,2year,3year
Secondary	requirement for escalation of drugs	observation	1year,2year,3year
Secondary	complication rate	toxic megacolon,perforation,carcinogenesis	1year,2year,3year