FIT Combining FC for Predicting MH and Histology Remission in UC

Sponsor

Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05447572

Collaborator

(none)

300

Enrollment

Location

27.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigaters will perform a clinical trial to asess the abilitiy of qFIT and FC on predicting UC MH and histology remission.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Histology Remission Fecal Calprotetin FIT Mucosal Healing	Other: FIT + FC

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

FIT Combining FC for Predicting MH and Histology Remission in UC

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Dec 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
FIT combingning FC with colonscopy	Other: FIT + FC FIT + FC

Arm

Intervention/Treatment

FIT combingning FC with colonscopy

Other: FIT + FC

FIT + FC

Outcome Measures

Primary Outcome Measures

diagnostic value of FIT and/without FC on predicting MH [2 weeks]
diagnostic value of FIT and/without FC on predicting MH, Mayo score will be used.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ulcerative colitis patients.

Exclusion Criteria:

GI bleeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qilu hospital of Shandong University	Jinan	Shandong	China	250012

Sponsors and Collaborators

Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanqing Li, Professor, Shandong University

ClinicalTrials.gov Identifier:

NCT05447572

Other Study ID Numbers:

2022SDU-QILU-1

First Posted:

Jul 7, 2022

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Study Results

No Results Posted as of Jul 7, 2022