Ulcerative ColitisRECT-USNCT06407674
Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US) in a Cohort of IBD Patients
An observational study of Ulcerative Colitis and Crohn's Disease, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
At enrollment, after informed consent form will be discussed and signed, subjects will undergo complete disease assessment. In this study, 150 adult subjects with IBD will be enrolled at the Gastroenterology Department of the San Raffaele Hospital (50 patients with Crohn's disease, 50 with Ulcerative colitis not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2024to 28 May 2025
- How long will I take part?
- 1 Day
- 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: 150 adult subjects (minimum age: 18 years) with IBD (established diagnosis since at least 3 months), specifically 50 with CD, 50 with UC not undergoing proctocolectomy, 50 with UC undergoing proctocolectomy with ileal pouch-anal anastomosis, irrespective of concomitant therapy, performing routine investigations with IC, according to the current standard of care indications and ECCO guidelines, will be assessed by both IUS and TPUS. Procedures performed routinely in clinical practice.
Who may be able to join
- Confirmed diagnosis of IBD for at least 3 months, in particular 50 with Crohn\&;s disease (CD), 50 with ulcerative colitis (UC) not undergoing proctocolectomy, 50 with ulcerative colitis (UC) undergoing proctocolectomy with ileal pouch-anal anastomosis
- Performing ileocolonoscopy, according to current standards of care and ECCO guidelines, will be assessed by both IUS and TPUS. Procedures performed routinely in clinical practice
- Ability to understand and comply with the study procedure and sign an informed consent form
Who cannot join
- Pregnancy;
- Concomitant intestinal infection (e.g. Clostridium difficile);
- Cirrhosis or intra-abdominal ascites.
- Subjects not able to comply with any study procedure;
- Subjects not able to understand and give informed consent form;
- Subjects with any contraindication to any study procedure.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Irccs San Rafael Hospital
Milan, 20132
Mariangela Allocca, Medicine and Surgey, allocca.mariangela@hsr.it
About this study
Official title: Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US): Multicentric, Observational and Cross-sectional Comparison Study With Colonoscopy in a Cohort of IBD Patients
At enrollment, after informed consent form will be discussed and signed, subjects will undergo complete disease assessment.
In this study, 150 adult subjects with IBD will be enrolled at the Gastroenterology Department of the San Raffaele Hospital (50 patients with Crohn's disease, 50 with Ulcerative colitis not undergoing proctocolectomy, and 50 with Ulcerative colitis undergoing proctocolectomy with ileal pouch-anal anastomosis).
Read more
All the patients will perform routine investigations with Ileocolonoscopy (IC), according to the current standard of care indications and ECCO guidelines, and they will be assessed by both Intestinal Ultrasound (IUS) and Trans-perineal ultrasound (TPUS). Blood and stool samples will be obtained for fecal calprotectin (FC) and C-reactive protein (CRP) measurements, respectively, as normal clinical practice.
All the procedures of this study are performed routinely in clinical practice. All the procedures are performed in a single day-visit for the patient.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- intestinal ultrasound, Ileocolonoscopy, Trans-perineal ultrasound
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ulcerative colitis | Not described | |
| crohn's disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of data
To correlate ultrasound finding, both transabdominally and transperineally, with endoscopic findings
Measured: 1 day (Cross Sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start10 Jan 2024
- Primary completion28 Nov 2024 (estimated)
- Study completion28 May 2025 (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.
- More trials run by IRCCS San RaffaeleThe 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariangela Allocca, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407674
- Sponsor's protocol ID
- RECT-US
- Acronym
- RECT-US
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US): Multicentric, Observational and Cross-sectional Comparison Study With Colonoscopy in a Cohort of IBD Patients
- ClinicalTrials.gov ID
- NCT06407674
- Acronym / sponsor ID
- RECT-US / RECT-US
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- intestinal ultrasound, Ileocolonoscopy, Trans-perineal ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 28 Nov 2024 (estimated)
- Study completion
- 28 May 2025 (estimated)
- First posted
- 9 May 2024 (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.
At enrollment, after informed consent form will be discussed and signed, subjects will undergo complete disease assessment.
In this study, 150 adult subjects with IBD will be enrolled at the Gastroenterology Department of the San Raffaele Hospital (50 patients with Crohn's disease, 50 with Ulcerative colitis not undergoing proctocolectomy, and 50 with Ulcerative colitis undergoing proctocolectomy with ileal pouch-anal anastomosis).
All the patients will perform routine investigations with Ileocolonoscopy (IC), according to the current standard of care indications and ECCO guidelines, and they will be assessed by both Intestinal Ultrasound (IUS) and Trans-perineal ultrasound (TPUS). Blood and stool samples will be obtained for fecal calprotectin (FC) and C-reactive protein (CRP) measurements, respectively, as normal clinical practice.
All the procedures of this study are performed routinely in clinical practice. All the procedures are performed in a single day-visit for the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ulcerative colitis | – | – |
| crohn's disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 adult subjects (minimum age: 18 years) with IBD (established diagnosis since at least 3 months), specifically 50 with CD, 50 with UC not undergoing proctocolectomy, 50 with UC undergoing proctocolectomy with ileal pouch-anal anastomosis, irrespective of concomitant therapy, performing routine investigations with IC, according to the current standard of care indications and ECCO guidelines, will be assessed by both IUS and TPUS. Procedures performed routinely in clinical practice.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of IBD for at least 3 months, in particular 50 with Crohn\&;s disease (CD), 50 with ulcerative colitis (UC) not undergoing proctocolectomy, 50 with ulcerative colitis (UC) undergoing proctocolectomy with ileal pouch-anal anastomosis
- Performing ileocolonoscopy, according to current standards of care and ECCO guidelines, will be assessed by both IUS and TPUS. Procedures performed routinely in clinical practice
- Ability to understand and comply with the study procedure and sign an informed consent form
Key exclusion criteria (6 listed)
- Pregnancy;
- Concomitant intestinal infection (e.g. Clostridium difficile);
- Cirrhosis or intra-abdominal ascites.
- Subjects not able to comply with any study procedure;
- Subjects not able to understand and give informed consent form;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation of data
Time frame: 1 day (Cross Sectional study)
To correlate ultrasound finding, both transabdominally and transperineally, with endoscopic findings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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 Crohn's Disease, run by IRCCS San Raffaele at 1 site in Italy.
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 6 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 9 May 2024. 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 Italy. 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 Mariangela Allocca, Medicine and Surgery (+390226432069, allocca.mariangela@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of data (time frame: 1 day (Cross Sectional study)). 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 9 May 2024.