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

NCT03698812 | Unknown DMC FDA Drug FDA Device

• 1 other identifier: LC2016PY007
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Prospective Study; Ulcerative Colitis in Remission

Keywords

Ulcerative Colitis; Mucosal Healing; Histological Remission; Prospective Study

Outcome Measures

Primary Outcomes (1)

• relapse rate

  CAI ≥5 or necessity for additional treatment

  1year

Secondary Outcomes (4)

• surgery rate

  1year，2year，3year

• Rehospitalization rate

  1year，2year，3year

• requirement for escalation of drugs

  1year，2year，3year

• complication rate

  1year，2year，3year

Study Arms (2)

CTL group

control group

Combination Product: Colonoscope

EXP group

Colonoscope

Combination Product: Colonoscope

Interventions

Colonoscope COMBINATION_PRODUCT

take off specimen

CTL group; EXP group

Eligibility Criteria

• Age: 14 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, sunwingwxy@163.com, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 17258735 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen retention will be kept as evidence to evaluate the condition of health.

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Colonoscopes

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopes, Gastrointestinal; Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• Xinying Wang

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinying Wang, MD

CONTACT

13726754880; sunwingwxy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-professor

Study Record Dates

• First Submitted: September 30, 2018
• First Posted: October 9, 2018
• Study Start: January 1, 2017
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2021
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1year,2year,3year
• Access Criteria: patients with ulcerative colitis in histological remission.

Locations

CN (1)