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

October 16, 2018 updated by: xinying wang, Nanfang Hospital of Southern Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, sunwingwxy@163.com
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CTL group
control group
Combination product: Colonoscope
take off specimen
EXP group
Colonoscope
Combination product: Colonoscope
take off specimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relapse rate
Time Frame: 1year
CAI ≥5 or necessity for additional treatment
1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgery rate
Time Frame: 1year，2year，3year
disease progress requiring surgery
1year，2year，3year
Rehospitalization rate
Time Frame: 1year，2year，3year
observation
1year，2year，3year
requirement for escalation of drugs
Time Frame: 1year，2year，3year
observation
1year，2year，3year
complication rate
Time Frame: 1year，2year，3year
toxic megacolon，perforation，carcinogenesis
1year，2year，3year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Xinying Wang, Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

September 30, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 16, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC2016PY007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

  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

IPD Sharing Time Frame

1year,2year,3year

IPD Sharing Access Criteria

patients with ulcerative colitis in histological remission.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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