Ulcerative ColitisPROCEED-UCNCT04408703
PRognOstiC valuE of rEd Density in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Red Density
- How many people
- 243 participants
- Where
- 2 sitesBelgium
- Study dates
- 3 Aug 2020to 1 Jun 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ulcerative colitis in clinical remission
Who may be able to join
- Confirmed diagnosis of UC for at least 3 months
- Clinical remission with SCCAI <3 at baseline and stable remission for the last 3 months
- Ability to give informed consent by the patient or legal representative in case of minority.
Who cannot join
- Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid.
- Uncontrolled coagulopathy.
- Any planned change in UC related treatment (both escalation and de-escalation) after the baseline endoscopy
- Planned UC related surgery
- Previous subtotal or total colectomy
- Short bowel, ileostomy or colostomy
- Pregnancy at baseline
- Age younger than 16 years
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Imelda GI clinical research center
Bonheiden, 2820
UZ Leuven
Leuven, 3000
About this study
Official title: PRognOstiC valuE of rEd Density in Ulcerative Colitis: PROCEED-UC STUDY
Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.
- Conditions
- Ulcerative Colitis
- Being tested
- Red Density
- Keywords
- Endoscopy, Artificial intelligence, Image analysis, Precision medicine, Inflammatory bowel disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red DensityDiagnostic test
Image analysis of endoscopic images in patients with ulcerative colitis
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis in clinical remission | Clinical remission with SCCAI <3 at baseline and stable remission for the last 3 months Receives: Diagnostic Test: Red Density |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained clinical remission
Number of patients with sustained clinical remission at week 52, defined as simple clinical colitis activity index (SCCAI) <3 AND no need for initiation of new treatment, escalation of therapy, UC related hospitalization or colectomy correlated to the RD score at baseline.
Measured: week 52
Secondary outcomes (2)
endoscopic remission Mayo
Number of patients with Mayo endoscopic subscore of 0 after 52 weeks correlated to the RD score at baseline.
Measured: week 52
endoscopic remission UCEIS
Number of patients with UCEIS of 0 after 52 weeks correlated to the RD score at baseline.
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start3 Aug 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Sapporo Medical University, Imelda GI Clinical Research Center
- Responsible party
- Sponsor
- Investigators
- Raf Bisschops, MD PhD, Principal investigator, UZ LeuvenPeter Bossuyt, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408703
- Sponsor's protocol ID
- s63012
- Acronym
- PROCEED-UC
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bossuyt P, Nakase H, Vermeire S, de Hertogh G, Eelbode T, Ferrante M, Hasegawa T, Willekens H, Ikemoto Y, Makino T, Bisschops R. Automatic, computer-aided determination of endoscopic and histological inflammation in patients with mild to moderate ulcerative colitis based on red density. Gut. 2020 Oct;69(10):1778-1786. doi: 10.1136/gutjnl-2019-320056. Epub 2020 Jan 8.
PubMed 31915237
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRognOstiC valuE of rEd Density in Ulcerative Colitis: PROCEED-UC STUDY
- ClinicalTrials.gov ID
- NCT04408703
- Acronym / sponsor ID
- PROCEED-UC / s63012
- Conditions
- Ulcerative Colitis
- Keywords
- Endoscopy, Artificial intelligence, Image analysis, Precision medicine, Inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Sapporo Medical University, Imelda GI Clinical Research Center
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 29 May 2020 (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.
Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis in clinical remission | – | Diagnostic Test: Red DensityClinical remission with SCCAI <3 at baseline and stable remission for the last 3 months |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ulcerative colitis in clinical remission
Key inclusion criteria (3 listed)
- Confirmed diagnosis of UC for at least 3 months
- Clinical remission with SCCAI <3 at baseline and stable remission for the last 3 months
- Ability to give informed consent by the patient or legal representative in case of minority.
Key exclusion criteria (8 listed)
- Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid.
- Uncontrolled coagulopathy.
- Any planned change in UC related treatment (both escalation and de-escalation) after the baseline endoscopy
- Planned UC related surgery
- Previous subtotal or total colectomy
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 |
|---|---|---|
| Red DensityImage analysis of endoscopic images in patients with ulcerative colitis | Diagnostic test | Ulcerative colitis in clinical remission |
Primary outcome
sustained clinical remission
Time frame: week 52
Number of patients with sustained clinical remission at week 52, defined as simple clinical colitis activity index (SCCAI) <3 AND no need for initiation of new treatment, escalation of therapy, UC related hospitalization or colectomy correlated to the RD score at baseline.
2 secondary outcomes
endoscopic remission Mayo
Time frame: week 52
endoscopic remission UCEIS
Time frame: week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 31915237Bossuyt P, Nakase H, Vermeire S, de Hertogh G, Eelbode T, Ferrante M, Hasegawa T, Willekens H, Ikemoto Y, Makino T, Bisschops R. Automatic, computer-aided determination of endoscopic and histological inflammation in patients with mild to moderate ulcerative colitis based on red density. Gut. 2020 Oct;69(10):1778-1786. doi: 10.1136/gutjnl-2019-320056. Epub 2020 Jan 8.
- 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.
Raf Bisschops, MD PhD principal investigator
UZ Leuven
Peter Bossuyt, MD principal investigator
UZ Leuven
2 sites 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, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sustained clinical remission (time frame: week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408703, which also lists 1 linked publication.
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 27 Jun 2024.