Predictive Factors of Endoscopic Mucosal Healing in Quies... | NCT02640391

Studies
Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis

NCT02640391

Sponsor

Kyungpook National University Hospital

Status

Completed

Last Update Posted

Aug 13, 2019Actual

Enrollment

127Actual

Phase

Not provided

Conditions

Ulcerative Colitis

Interventions

colonoscopy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Dec 15, 2015

First Submission Date that Met QC Criteria

Dec 22, 2015

First Posted Date

Dec 29, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2019

Last Update Posted Date

Aug 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eun Soo Kim, MD, PhD, Professor, Kyungpook National University HospitalPrincipal Investigator

Lead Sponsor

Kyungpook National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether fecal calprotectin, fecal immunochemical test, and Rome III criteria for irritable bowel syndrome (IBS) can predict mucosal healing in patients with quiescent ulcerative colitis (UC).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

127Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quiescent UC		Patients with quiscent UC who will undergo colonoscopy for surveillance or mucosal healing check up	Other: colonoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
colonoscopy	Other		Quiescent UC	fecal calprotectin fecal immunochemical test Rome III criteria for IBS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mucosal healing	Endoscopic Mayo subscore <1	1 week
Fecal calprotectin		1 week
Fecal immunochemical test		1 week

Secondary Outcomes

Measure	Description	Time Frame
Rome III criteria for IBS		1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with ulcerative colitis who have no change of medication for at least 6 months
Patients with ulcerative colitis who are in remission (Mayo score <3)
Patients with ulcerative colitis who will undergo colonoscopy for surveillance or mucosal healing check-up

Exclusion Criteria:

Patients who refuse to participate
Patients who have a history of colectomy
Patients who have instinal stricture or perforation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with inactive UC (Mayo score <3) who are scheduled to undergo colonoscopy for surveillance or mucosal healing check-up

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eun Soo Kim, MD, PhD	Keimyung University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keimyung University Dongsan Medical Center		Daegu		700-712	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003113	Colonoscopy

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided