Ulcerative ColitisCONF-UCNCT06624579
Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis: the CONF-UC Study
A study testing confocal endomicroscopy in people with Ulcerative Colitis, run by FEDERICA FURFARO.
Trial summary
This study employs a prospective, single-center, interventional design to investigate the prognostic value of confocal endomicroscopy in assessing treatment response in ulcerative colitis (UC) patients receiving small molecules . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- confocal endomicroscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Jun 2026
- Phase
- Interventional
- 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
Who may be able to join
- Established diagnosis of UC since at least 12 weeks prior to inclusion
- Age ≥ 18 years
- Any gender/sex
- Active disease consistent with indication to start with Small molecules (defined as Mayo endoscopic score (MES) ≥ 1, partial Mayo score ≥ 3 (with at least rectal bleeding score of 1 and bowel movements score of 1)
- No contraindications to endoscopy or confocal exam
- Ability to understand and to comply with the study procedure and sign an informed consent form
Who cannot join
- Subjects with an endoscopic Mayo sub-score at baseline \<2;
- Pregnancy
- Subjects with any contraindication to any study procedure (included fluorescein allergy).
Trial locations and contacts
No sites are listed yet.
About this study
This study employs a prospective, single-center, interventional design to investigate the prognostic value of confocal endomicroscopy in assessing treatment response in ulcerative colitis (UC) patients receiving small molecules .
Read the detailed description
The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.
Eligible patients will undergo baseline assessment, including clinical evaluation, partial Mayo score calculation, endoscopic evaluation, biopsies with histological evaluation and confocal endomicroscopy. Follow-up assessments will be conducted at 8 weeks and 6 months after initiating therapy with small molecules .
The study aims to enroll a sample size of 26 UC patients to pilot the feasibility and utility of confocal endomicroscopy in assessing barrier dysfunction and treatment response.
- Conditions
- Ulcerative Colitis
- Being tested
- confocal endomicroscopy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
confocal endomicroscopyProcedure or surgery
The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.
| Study group | Role | What they receive |
|---|---|---|
| confocal endomicroscopy | Other | Endoscopic confocal microscopy with fluorescein injection is a medical imaging technique that combines endoscopy with confocal microscopy and the injection of fluorescein, a fluorescent dye.
During colonoscopy or rettosigmoidoscopy, confocal microscopy is used, which provides high-resolution images of tissues at a cellular level. This technology uses a thin probe with a laser light source and a detection system to analyze specific layers of tissue. During the examination, a solution of fluorescein is injected into the patient's peripheric vein. Fluorescein is a dye that binds to cellular structures, making them fluorescent when exposed to laser light. This allows to visualize cellular details in real-time during endoscopy Receives: Procedure: confocal endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis
The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.
Measured: at 8 weeks and 6 months to treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJun 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 26 adult subjects with moderate-to-severe active (defined as having patient-reported outcomes, PRO \> 2), left-sided or extensive UC, requiring small molecules therapy according to the standards of care (ECCO guidelines) and performing routine investigations with Colonoscopy before starting appropriate therapy, according to the current standard of care indications and ECCO guidelines.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FEDERICA FURFARO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, FEDERICA FURFARO, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624579
- Sponsor's protocol ID
- IRCCS SAN RAFAEL HOSPITAL
- Acronym
- CONF-UC
- Status last verified
- Oct 2024
- First submitted
- 21 Aug 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis: the CONF-UC Study
- ClinicalTrials.gov ID
- NCT06624579
- Acronym / sponsor ID
- CONF-UC / IRCCS SAN RAFAEL HOSPITAL
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- FEDERICA FURFAROUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Oct 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.
This study employs a prospective, single-center, interventional design to investigate the prognostic value of confocal endomicroscopy in assessing treatment response in ulcerative colitis (UC) patients receiving small molecules .
Detailed description
The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.
Eligible patients will undergo baseline assessment, including clinical evaluation, partial Mayo score calculation, endoscopic evaluation, biopsies with histological evaluation and confocal endomicroscopy. Follow-up assessments will be conducted at 8 weeks and 6 months after initiating therapy with small molecules .
The study aims to enroll a sample size of 26 UC patients to pilot the feasibility and utility of confocal endomicroscopy in assessing barrier dysfunction and treatment response.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 26 adult subjects with moderate-to-severe active (defined as having patient-reported outcomes, PRO \> 2), left-sided or extensive UC, requiring small molecules therapy according to the standards of care (ECCO guidelines) and performing routine investigations with Colonoscopy before starting appropriate therapy, according to the current standard of care indications and ECCO guidelines.
| Arm | Type | Receives |
|---|---|---|
| confocal endomicroscopy | Other | Procedure: confocal endomicroscopyEndoscopic confocal microscopy with fluorescein injection is a medical imaging technique that combines endoscopy with confocal microscopy and the injection of fluorescein, a fluorescent dye. During colonoscopy or rettosigmoidoscopy, confocal microscopy is used, which provides high-resolution images of tissues at a cellular level. This technology uses a thin probe with a laser light source and a detection system to analyze specific layers of tissue. During the examination, a solution of fluorescein is injected into the patient's peripheric vein. Fluorescein is a dye that binds to cellular structures, making them fluorescent when exposed to laser light. This allows to visualize cellular details in real-time during endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Established diagnosis of UC since at least 12 weeks prior to inclusion
- Age ≥ 18 years
- Any gender/sex
- Active disease consistent with indication to start with Small molecules (defined as Mayo endoscopic score (MES) ≥ 1, partial Mayo score ≥ 3 (with at least rectal bleeding score of 1 and bowel movements score of 1)
- No contraindications to endoscopy or confocal exam
Key exclusion criteria (3 listed)
- Subjects with an endoscopic Mayo sub-score at baseline \<2;
- Pregnancy
- Subjects with any contraindication to any study procedure (included fluorescein allergy).
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 |
|---|---|---|
| confocal endomicroscopyThe study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing. | Procedure or surgery | confocal endomicroscopy |
Primary outcome
Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis
Time frame: at 8 weeks and 6 months to treatment initiation
The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing confocal endomicroscopy in people with Ulcerative Colitis, run by FEDERICA FURFARO.
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 6 inclusion and 3 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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 FEDERICA FURFARO GASTROENTEROLOGIST (0039+0226432069, furfaro.federica@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis (time frame: at 8 weeks and 6 months to treatment initiation). 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 3 Oct 2024.