Colitis, UlcerativeENHANCENCT02676817
Confocal Laser Endomicroscopy for Assessment of Mucosal Healing in Ulcerative Colitis
An observational study of Colitis, Ulcerative, run by European Georges Pompidou Hospital at 1 site in France.
Trial summary
The aim of the study is to construct and validate an endomicroscopic score correlated with microscopic inflammation activity in patients with UC. Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which offers the possibility to perform in vivo mucosal microscopic analysis in real… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Feb 2017
- 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: Patients with UC who need control coloscopy
Who may be able to join
- Age 18 years or older
- Diagnosis of UC established at least for three months, according to the Lennard-Jones' criteria. Two sub-groups will be studied as follows;
- Group 1 (n=70) = UC in remission regardless of the medication that allowed remission nor taken by the patient (Mayo' sub-score 0 or 1) and who require colonoscopy regardless of the study according to current guidelines (screening for dysplasia, monitoring during treatment etc).
- Group 2 (n=30) = Active UC (Mayo' sub-score 2 or 3) requiring adalimumab and for whom a rectosigmoidoscopy should be performed 8 weeks after starting therapy, according to current french guidelines. Eight weeks after the treatment is the minimum time necessary to evaluate the effects of this treatment according the current practice in France. Then, investigators chose in our study to assess the effects in the group 2 at 8 weeks. All the 30 patients in group 2 will receive adalimumab and they will be treatment-naïve patients.
- Informed consent obtained from the patient
Who cannot join
- Allergy to fluorescein
- Pregnancy
- Refusal to participate to the study or inability to consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Europeén Georges Pompidou
Paris, 75015
Gabriel Rahmi, MD, 33156395968, gabriel.rahmi@egp.aphp.fr
About this study
Official title: Probe-based Confocal Laser Endomicroscopy for Assessment of Mucosal Healing in Ulcerative Colitis: Development and Validation of the ENHANCE Score
The aim of the study is to construct and validate an endomicroscopic score correlated with microscopic inflammation activity in patients with UC.
Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which offers the possibility to perform in vivo mucosal microscopic analysis in real time during endoscopy.
Read more
Primary Objectives : Development and validation of a UC endomicroscopic score, after correlation between pCLE data and histological data using the Geboes' score as a gold standard during ulcerative colitis.
Secondary Objectives:
- Identify predictive factors for the response to adalimumab.
- Identify predictive factors for recurrence in patients with UC in remission (Mayo score 0 or 1).
- Safety of the pCLE procedure
Read the detailed description
Informed consent will be obtained before colonoscopy that includes the known risks and benefits related to the procedure according to the standard protocol of the physician and institution.
A separate informed consent document to participate in the study specific to the approach, technology will be executed.
- Operator's training before the beginning of the study Thirty short pCLE video sequences will be sent to each investigator. Video sequence contains pCLE images of mucosal inflammation in a patient with UC. For each video the correlation with histology is known. The investigator will have to recognize the different pCLE inflammation criteria (Annex 2) and a 90% correct response rate will be required.
- Endoscopic procedures
MACROSCOPIC examination: colonoscopy
Bowel preparation according to standard protocol was used for colonoscopy. During the colonoscopy, the rectal and colonic mucosal will be analysed with high resolution white light (with or without virtual chromoendoscopy). Before pCLE examination and according to current guidelines, targeted biopsies will be taken in every suspected area of dysplasia for specific histological examination.
MICROSCOPIC examination: pCLE (Cellvizio)
pCLE examination will be done after intravenous injection of fluoresceine (2.5 ml), with the monitoring of cardiovascular and respiratory functions. Three defined area will be analysed: right colon, left colon (40cm from the anus) and the rectum (10cm). Real time analysis and re-reading after the colonoscopy will be done for the video sequences recording during the procedure. A double-blind analysis for each video sequence will be done by two experienced endoscopists.
Rectal and colonic biopsies
For each location (right colon, left colon and rectum), 4 macroscopic area will be indentified (anterior, posterior, left and right), recorded (endoscopic images) and the mucosal inflammation will be scored according to the Mayo's and UCEIS classifications. Then, the probe using for the pCLE procedure will be applied on these 4 different areas and video sequences will be recorded ("optical biopsies"). At the end of the procedure, biopsies will be taken from each area. Each biopsy will have a registration number and the corresponding pCLE video sequence will be specified.
For each location (right colon, left colon, rectum), the final score of inflammation (macroscopic or microscopic) will be define by the higher score recorded in the 4 areas (anterior, posterior, left and righ).
Sensibility to change
For the patients with active UC in group 2 (Mayo' sub-score 2 or 3), a rectosigmoidoscopy should be performed 8 weeks after starting therapy, according to current french guidelines. In order to compare the pCLE examination before and after adalimumab therapy in the group 2, each area will be identified with a submucosal injection of Indian ink.
- Conditions
- Colitis, Ulcerative
- Keywords
- colitis, endoscopy
- Medical subject headings
- Colitis, Ulcerative, Colitis
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 |
|---|---|---|
| Group 1 | Group 1 (n=70) = UC in remission regardless of the medication that allowed remission nor taken by the patient (Mayo' sub-score 0 or 1) and who require colonoscopy regardless of the study according to current guidelines (screening for dysplasia, monitoring during treatment etc). | |
| Group 2 | Group 2 (n=30) = Active UC (Mayo' sub-score 2 or 3) requiring adalimumab and for whom a rectosigmoidoscopy will be performed 8 to 12 weeks after starting therapy, according to current French guidelines and routine practice. Eight weeks after the treatment is the minimum time necessary to evaluate the effects of this treatment according the current practice in France. Then, investigators chose in our study to assess the effects in the group 2 at 8 weeks. All the 30 patients in group 2 will receive adalimumab and they will be anti-TNF naïve patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation assessment by pCLE videos and standard histology
Inflammation will be present if ONE or MORE of the following criteria will be showed by the pCLE examination (the number of criteria will be defined "a posteriori" after comparison with the histological results):
- crypt: : number (0-10), size (10 to 200 micrometers), distance between 2 crypts (increase or normal)
- cells : number (0 to 50), color (white or black)
- vessels : number, diamter (> or < 20 micrometers)
- fluoresceine leakage (yes or no)
Measured: 6 months
Secondary outcomes (1)
Changes in pCLE criteria after adalimumab and safety of pCLE
Inflammation will be present if ONE or MORE of the following criteria will be showed by the pCLE examination (the number of criteria will be defined "a posteriori" after comparison with the histological results):
- crypt: : number (0-10), size (10 to 200 micrometers), distance between 2 crypts (increase or normal)
- cells : number (0 to 50), color (white or black)
- vessels : number, diamter (> or < 20 micrometers)
- fluoresceine leakage (yes or no) pCLE safety (intravenous fluoresceine): cardiological trouble: yes or no allergy (yes or no)
Measured: 6 or 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAHMI Gabriel, European Georges Pompidou Hospital
- Investigators
- gabriel rahmi, MD, Principal investigator, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676817
- Sponsor's protocol ID
- 2014-A00990-47
- Acronym
- ENHANCE
- Status last verified
- Feb 2016
- First submitted
- 14 Aug 2015
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probe-based Confocal Laser Endomicroscopy for Assessment of Mucosal Healing in Ulcerative Colitis: Development and Validation of the ENHANCE Score
- ClinicalTrials.gov ID
- NCT02676817
- Acronym / sponsor ID
- ENHANCE / 2014-A00990-47
- Conditions
- Colitis, Ulcerative
- Keywords
- colitis, endoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 8 Feb 2016 (estimated)
- 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.
The aim of the study is to construct and validate an endomicroscopic score correlated with microscopic inflammation activity in patients with UC.
Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which offers the possibility to perform in vivo mucosal microscopic analysis in real time during endoscopy.
Primary Objectives : Development and validation of a UC endomicroscopic score, after correlation between pCLE data and histological data using the Geboes' score as a gold standard during ulcerative colitis.
Secondary Objectives:
- Identify predictive factors for the response to adalimumab.
- Identify predictive factors for recurrence in patients with UC in remission (Mayo score 0 or 1).
- Safety of the pCLE procedure
Detailed description
Informed consent will be obtained before colonoscopy that includes the known risks and benefits related to the procedure according to the standard protocol of the physician and institution.
A separate informed consent document to participate in the study specific to the approach, technology will be executed.
- Operator's training before the beginning of the study Thirty short pCLE video sequences will be sent to each investigator. Video sequence contains pCLE images of mucosal inflammation in a patient with UC. For each video the correlation with histology is known. The investigator will have to recognize the different pCLE inflammation criteria (Annex 2) and a 90% correct response rate will be required.
- Endoscopic procedures
MACROSCOPIC examination: colonoscopy
Bowel preparation according to standard protocol was used for colonoscopy. During the colonoscopy, the rectal and colonic mucosal will be analysed with high resolution white light (with or without virtual chromoendoscopy). Before pCLE examination and according to current guidelines, targeted biopsies will be taken in every suspected area of dysplasia for specific histological examination.
MICROSCOPIC examination: pCLE (Cellvizio)
pCLE examination will be done after intravenous injection of fluoresceine (2.5 ml), with the monitoring of cardiovascular and respiratory functions. Three defined area will be analysed: right colon, left colon (40cm from the anus) and the rectum (10cm). Real time analysis and re-reading after the colonoscopy will be done for the video sequences recording during the procedure. A double-blind analysis for each video sequence will be done by two experienced endoscopists.
Rectal and colonic biopsies
For each location (right colon, left colon and rectum), 4 macroscopic area will be indentified (anterior, posterior, left and right), recorded (endoscopic images) and the mucosal inflammation will be scored according to the Mayo's and UCEIS classifications. Then, the probe using for the pCLE procedure will be applied on these 4 different areas and video sequences will be recorded ("optical biopsies"). At the end of the procedure, biopsies will be taken from each area. Each biopsy will have a registration number and the corresponding pCLE video sequence will be specified.
For each location (right colon, left colon, rectum), the final score of inflammation (macroscopic or microscopic) will be define by the higher score recorded in the 4 areas (anterior, posterior, left and righ).
Sensibility to change
For the patients with active UC in group 2 (Mayo' sub-score 2 or 3), a rectosigmoidoscopy should be performed 8 weeks after starting therapy, according to current french guidelines. In order to compare the pCLE examination before and after adalimumab therapy in the group 2, each area will be identified with a submucosal injection of Indian ink.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Group 1 (n=70) = UC in remission regardless of the medication that allowed remission nor taken by the patient (Mayo' sub-score 0 or 1) and who require colonoscopy regardless of the study according to current guidelines (screening for dysplasia, monitoring during treatment etc). |
| Group 2 | – | –Group 2 (n=30) = Active UC (Mayo' sub-score 2 or 3) requiring adalimumab and for whom a rectosigmoidoscopy will be performed 8 to 12 weeks after starting therapy, according to current French guidelines and routine practice. Eight weeks after the treatment is the minimum time necessary to evaluate the effects of this treatment according the current practice in France. Then, investigators chose in our study to assess the effects in the group 2 at 8 weeks. All the 30 patients in group 2 will receive adalimumab and they will be anti-TNF naïve patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with UC who need control coloscopy
Key inclusion criteria (5 listed)
- Age 18 years or older
- Diagnosis of UC established at least for three months, according to the Lennard-Jones' criteria. Two sub-groups will be studied as follows;
- Informed consent obtained from the patient
Key exclusion criteria (3 listed)
- Allergy to fluorescein
- Pregnancy
- Refusal to participate to the study or inability to consent
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
Inflammation assessment by pCLE videos and standard histology
Time frame: 6 months
Inflammation will be present if ONE or MORE of the following criteria will be showed by the pCLE examination (the number of criteria will be defined "a posteriori" after comparison with the histological results): * crypt: : number (0-10), size (10 to 200 micrometers), distance between 2 crypts (increase or normal) * cells : number (0 to 50), color (white or black) * vessels : number, diamter (> or < 20 micrometers) * fluoresceine leakage (yes or no)
1 secondary outcome
Changes in pCLE criteria after adalimumab and safety of pCLE
Time frame: 6 or 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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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.
gabriel rahmi, MD principal investigator
European Georges Pompidou Hospital
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 Colitis, Ulcerative, run by European Georges Pompidou Hospital at 1 site in France.
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 5 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 8 Feb 2016. 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 France. 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 Gabriel Rahmi, MD (33156095968, gabriel.rahmi@egp.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation assessment by pCLE videos and standard histology (time frame: 6 months). 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 8 Feb 2016.