Inflammatory Bowel DiseasesNCT05576402
Endoscopic Scoring System Utilization in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno at 1 site in Argentina.
Trial summary
Inflammatory bowel diseases comprise two distinctive entities: Crohn's disease and ulcerative colitis. During the last decade, endoscopic assessment of inflammation has become relevant since it is a prognostic factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteArgentina
- Study dates
- 2 May 2022to 20 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who have already received a diagnosis of either Crohn's disease or ulcerative colitis
Who may be able to join
- Adult patients who underwent colonoscopy for the evaluation of mucosal inflammatory activity
- Patients with an established diagnosis of either Crohn's disease or ulcerative colitis
Who cannot join
- Sigmoidoscopies performed in ulcerative colitis for the assessment of mucosal inflammatory activity
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
CEMIC
Buenos Aires, 1425
Juan S Lasa, MD, 541140848182, drjuanslasa@gmail.com
About this study
Official title: Endoscopic Scoring System Utilization for Inflammatory Bowel Disease Activity Assessment
Inflammatory bowel diseases comprise two distinctive entities: Crohn's disease and ulcerative colitis. During the last decade, endoscopic assessment of inflammation has become relevant since it is a prognostic factor. As a consequence, therapeutic targets now contemplate mucosal healing as part of the goals to be achieved. Endoscopic scores for Crohn's disease and ulcerative colitis have been developed to objectively assess the mucosal inflammatory activity. Although they may have some limitations, these scores have been widely accepted in referral centers, especially since they have been adopted as standard evaluation in inflammatory bowel disease clinical trials . However, their use in the setting of endoscopic practice outside centers with a high volume or with less experience in clinical trials is not known.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- colonoscopy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
Also called endoscopic score assessment
endoscopic exploration of colonic mucosa to evaluate inflammatory activity in patients with either Crohn's disease or ulcerative colitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic score report
Proportion of colonoscopy reports among inflammatory bowel disease patients which include an endoscopic score to assess inflammatory activity
Measured: January 2018-October 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start2 May 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion20 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Lasa, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- Investigators
- Juan S Lasa, MD, Principal investigator, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576402
- Sponsor's protocol ID
- 333
- Status last verified
- Dec 2022
- First submitted
- 8 Oct 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Scoring System Utilization for Inflammatory Bowel Disease Activity Assessment
- ClinicalTrials.gov ID
- NCT05576402
- Acronym / sponsor ID
- 333
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto QuirnoUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 12 Oct 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.
Inflammatory bowel diseases comprise two distinctive entities: Crohn's disease and ulcerative colitis. During the last decade, endoscopic assessment of inflammation has become relevant since it is a prognostic factor. As a consequence, therapeutic targets now contemplate mucosal healing as part of the goals to be achieved. Endoscopic scores for Crohn's disease and ulcerative colitis have been developed to objectively assess the mucosal inflammatory activity. Although they may have some limitations, these scores have been widely accepted in referral centers, especially since they have been adopted as standard evaluation in inflammatory bowel disease clinical trials . However, their use in the setting of endoscopic practice outside centers with a high volume or with less experience in clinical trials is not known.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have already received a diagnosis of either Crohn's disease or ulcerative colitis
Key inclusion criteria (2 listed)
- Adult patients who underwent colonoscopy for the evaluation of mucosal inflammatory activity
- Patients with an established diagnosis of either Crohn's disease or ulcerative colitis
Key exclusion criteria (1 listed)
- Sigmoidoscopies performed in ulcerative colitis for the assessment of mucosal inflammatory activity
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 |
|---|---|---|
| colonoscopyAlso: endoscopic score assessmentendoscopic exploration of colonic mucosa to evaluate inflammatory activity in patients with either Crohn's disease or ulcerative colitis | Procedure or surgery | – |
Primary outcome
Endoscopic score report
Time frame: January 2018-October 2022
Proportion of colonoscopy reports among inflammatory bowel disease patients which include an endoscopic score to assess inflammatory activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Juan S Lasa, MD principal investigator
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
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 Inflammatory Bowel Diseases, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno at 1 site in Argentina.
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 2 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 28 Dec 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 Argentina. 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 Juan S Lasa, MD (541140848182, juanselasa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic score report (time frame: January 2018-October 2022). 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 28 Dec 2022.