Ulcerative ColitisNCT05447572
FIT Combining FC for Predicting MH and Histology Remission in UC
An observational study of Ulcerative Colitis and Histology Remission, run by Shandong University at 1 site in China.
Trial summary
Investigaters will perform a clinical trial to asess the abilitiy of qFIT and FC on predicting UC MH and histology remission. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis, Histology Remission, Fecal Calprotetin
- What is being tested?
- FIT + FC
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 12 Dec 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ulcerative colitis patients.
Who may be able to join
- Ulcerative colitis patients.
Who cannot join
- GI bleeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hospital of Shandong University
Jinan, Shandong, 250012
Yan Zhang, DOC, +86-18560089821, qlzhangyan@qq.com
About this study
Investigaters will perform a clinical trial to asess the abilitiy of qFIT and FC on predicting UC MH and histology remission.
- Conditions
- Ulcerative Colitis, Histology Remission, Fecal Calprotetin, FIT, Mucosal Healing
- Being tested
- FIT + FC
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT + FCOther
FIT + FC
| Study group | Role | What they receive |
|---|---|---|
| FIT combingning FC with colonscopy | Not described Receives: Other: FIT + FC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Sep 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion12 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447572
- Sponsor's protocol ID
- 2022SDU-QILU-1
- Status last verified
- Nov 2022
- First submitted
- 5 Jan 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIT Combining FC for Predicting MH and Histology Remission in UC
- ClinicalTrials.gov ID
- NCT05447572
- Acronym / sponsor ID
- 2022SDU-QILU-1
- Conditions
- Ulcerative Colitis, Histology Remission, Fecal Calprotetin, FIT, Mucosal Healing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 12 Dec 2023 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigaters will perform a clinical trial to asess the abilitiy of qFIT and FC on predicting UC MH and histology remission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIT combingning FC with colonscopy | – | Other: FIT + FC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ulcerative colitis patients.
Key inclusion criteria (1 listed)
- Ulcerative colitis patients.
Key exclusion criteria (1 listed)
- GI bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIT + FCFIT + FC | Other | FIT combingning FC with colonscopy |
Primary outcome
diagnostic value of FIT and/without FC on predicting MH
Time frame: 2 weeks
diagnostic value of FIT and/without FC on predicting MH, Mayo score will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Histology Remission, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhang, DOC (+86-18560089821, qlzhangyan@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic value of FIT and/without FC on predicting MH (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.