NCT05447572

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

January 5, 2022

Last Update Submit

November 14, 2022

Conditions

Ulcerative ColitisHistology RemissionFecal CalprotetinFITMucosal Healing

Outcome Measures

Primary Outcomes (1)

  • diagnostic value of FIT and/without FC on predicting MH

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

    2 weeks

Study Arms (1)

FIT combingning FC with colonscopy

Other: FIT + FC

Interventions

FIT + FCOTHER

FIT + FC

FIT combingning FC with colonscopy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ulcerative colitis patients.

You may qualify if:

  • Ulcerative colitis patients.

You may not qualify if:

  • GI bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Each colonoscopies will get common biospies

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Yan Zhang, DOC

CONTACT

+86-18560089821qlzhangyan@qq.com

Yihao Song, DOC

CONTACT

+86-13165133773781975756@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2022

First Posted

July 7, 2022

Study Start

September 1, 2021

Primary Completion

December 30, 2022

Study Completion

December 12, 2023

Last Updated

November 15, 2022

Record last verified: 2022-11

Locations

CN(1)