Inflammatory Bowel DiseaseCENCT02543762
Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease and Colorectal Cancer, run by Hospital Clinic of Barcelona at 15 sites in Spain.
Trial summary
To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted biopsies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Colorectal Cancer
- What is being tested?
- Chromoendoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 15 sitesSpain
- Study dates
- Feb 2012to May 2015
- How long will I take part?
- 2 Years
- 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: Prospective, multicenter, multicenter study, coordinated by the Department of Gastroenterology, Hospital Clínic of Barcelona
Who may be able to join
- Diagnosis of UC or colitis EC corroborated by clinical and histology
- involvement of at least one third of the colon in patients with CD
- involvement proximal to the rectum in patients with UC
- Duration of disease > 10 years
- No clinical activity:
- May Score <6
- CDEIS <3.5
Who cannot join
- Personal history of CRC
- colectomy
- coagulopathy
- refusal to participate in the study
- known allergy to indigo carmine
- colonoscopy in the last 6 months
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Gastroenteroly Department, Hospital Clinic
Barcelona, Barcelona, 08036
Hospital de Sant Pau
Barcelona, Barcelona
Hospital del Mar
Barcelona, Barcelona
Hospital Sant Jaume de Calella
Calella, Barcelona
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Hospital 12 de Octubre
Madrid, Madrid
Hospital Puerta del Hierro
Madrid, Madrid
Hospital Ramón y Cajal
Madrid, Madrid
Hospital General de Manresa
Manresa, Barcelona, 08240
Hospital general de Mostoles
Móstoles, Madrid
Complexo Hospitalario Universitario de Ourense
Ourense, Pontevedra, 32005
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife
Hospital de la Fe
Valencia, Valencia
Hospital Peset
Valencia, Valencia
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra
About this study
To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted biopsies
Read the detailed description
We aim to know the prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain and the usefulness of advanced endoscopy (chromoendoscopy) for the diagnosis and endoscopic differential diagnosis of N-IBD.
- Conditions
- Inflammatory Bowel Disease, Colorectal Cancer
- Being tested
- Chromoendoscopy
- Keywords
- Chromoendoscopy, Ulcerative Colitis, Crohn disease, Colorectal Neoplasia
- Medical subject headings
- Inflammatory Bowel Diseases, Colorectal Neoplasms, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChromoendoscopyProcedure or surgery
Chromoendoscopy involves the topical application of stains to improve tissue localization and characterization of lessions during endoscopy . Chromoendoscopy has been used in patients undergoing colonoscopy, including those undergoing surveillance for chronic ulcerative colitis. Using pit pattern classifications, chromoendoscopy has a high sensitivity and specificity for differentiating neoplastic from non-neoplastic lesions
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease | Inflammatory bowel disease (IBD) is comprised of two major disorders: ulcerative colitis and Crohn disease.
Ulcerative colitis is a chronic inflammatory condition characterized by relapsing and remitting episodes of inflammation limited to the mucosal layer of the colon. It almost invariably involves the rectum and typically extends in a proximal and continuous fashion to involve other portions of the colon.
Crohn disease is characterized by transmural inflammation and by skip lesions. The transmural inflammatory nature of Crohn disease may lead to fibrosis and strictures, and to obstructive clinical presentations that are not typically seen in ulcerative colitis. More commonly, the transmural inflammation results in sinus tracts, giving rise to microperforations and fistulae.
Crohn disease may involve the entire gastrointestinal tract from mouth to perianal área patients with long-standing inflammatory bowel disease are prone to the development of colorectal cancer Receives: Procedure: Chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain
see title
Measured: two year
Secondary outcomes (1)
Usefulness of advanced endoscopy in displasia characterization (chromoendoscopy ) for the diagnosis and endoscopic differential diagnosis of NIBD.
see title
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startFeb 2012
- Primary completionJun 2014
- Study completionMay 2015
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 Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- 350 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Complexo Hospitalario de Ourense, Hospital de Manresa, Hospital Universitario Ramon y Cajal, Hospital Universitario 12 de Octubre, Hospital de Calella, Hospital General de Mostoles, Hospital del Mar, Hospital Universitario La Fe, Puerta de Hierro University Hospital, Hospital Universitario de Canarias, Hospital Universitari de Bellvitge, Hospital de Sant Pau, Complejo Hospitalario Universitario de Vigo, Hospital Universitario Doctor Peset
- Responsible party
- Principal investigator, Maria Lopez Ceron, Hospital Clinic of Barcelona
- Investigators
- Maria Pellise, MDPHD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543762
- Sponsor's protocol ID
- 3-Ceron
- Acronym
- CE
- Status last verified
- Sep 2015
- First submitted
- 20 May 2014
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Carballal S, Maisterra S, Lopez-Serrano A, Gimeno-Garcia AZ, Vera MI, Marin-Garbriel JC, Diaz-Tasende J, Marquez L, Alvarez MA, Hernandez L, De Castro L, Gordillo J, Puig I, Vega P, Bustamante-Balen M, Acevedo J, Penas B, Lopez-Ceron M, Ricart E, Cuatrecasas M, Jimeno M, Pellise M; EndoCAR group of the Spanish Gastroenterological Association and Spanish Digestive Endoscopy Society. Real-life chromoendoscopy for neoplasia detection and characterisation in long-standing IBD. Gut. 2018 Jan;67(1):70-78. doi: 10.1136/gutjnl-2016-312332. Epub 2016 Sep 9.
PubMed 27612488
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02543762
- Acronym / sponsor ID
- CE / 3-Ceron
- Conditions
- Inflammatory Bowel Disease, Colorectal Cancer
- Keywords
- Chromoendoscopy, Ulcerative Colitis, Crohn disease, Colorectal Neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Complexo Hospitalario de Ourense, Hospital de Manresa, Hospital Universitario Ramon y Cajal, Hospital Universitario 12 de Octubre, Hospital de Calella, Hospital General de Mostoles, Hospital del Mar, Hospital Universitario La Fe, Puerta de Hierro University Hospital, Hospital Universitario de Canarias, Hospital Universitari de Bellvitge, Hospital de Sant Pau, Complejo Hospitalario Universitario de Vigo, Hospital Universitario Doctor Peset
- Study start
- Feb 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Sep 2015 (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.
To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted biopsies
Detailed description
We aim to know the prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain and the usefulness of advanced endoscopy (chromoendoscopy) for the diagnosis and endoscopic differential diagnosis of N-IBD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease | – | Procedure: ChromoendoscopyInflammatory bowel disease (IBD) is comprised of two major disorders: ulcerative colitis and Crohn disease. Ulcerative colitis is a chronic inflammatory condition characterized by relapsing and remitting episodes of inflammation limited to the mucosal layer of the colon. It almost invariably involves the rectum and typically extends in a proximal and continuous fashion to involve other portions of the colon. Crohn disease is characterized by transmural inflammation and by skip lesions. The transmural inflammatory nature of Crohn disease may lead to fibrosis and strictures, and to obstructive clinical presentations that are not typically seen in ulcerative colitis. More commonly, the transmural inflammation results in sinus tracts, giving rise to microperforations and fistulae. Crohn disease may involve the entire gastrointestinal tract from mouth to perianal área patients with long-standing inflammatory bowel disease are prone to the development of colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective, multicenter, multicenter study, coordinated by the Department of Gastroenterology, Hospital Clínic of Barcelona
Key inclusion criteria (7 listed)
- Diagnosis of UC or colitis EC corroborated by clinical and histology
- involvement of at least one third of the colon in patients with CD
- involvement proximal to the rectum in patients with UC
- Duration of disease > 10 years
- No clinical activity:
Key exclusion criteria (6 listed)
- Personal history of CRC
- colectomy
- coagulopathy
- refusal to participate in the study
- known allergy to indigo carmine
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 |
|---|---|---|
| ChromoendoscopyChromoendoscopy involves the topical application of stains to improve tissue localization and characterization of lessions during endoscopy . Chromoendoscopy has been used in patients undergoing colonoscopy, including those undergoing surveillance for chronic ulcerative colitis. Using pit pattern classifications, chromoendoscopy has a high sensitivity and specificity for differentiating neoplastic from non-neoplastic lesions | Procedure or surgery | Inflammatory Bowel Disease |
Primary outcome
Prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain
Time frame: two year
see title
1 secondary outcome
Usefulness of advanced endoscopy in displasia characterization (chromoendoscopy ) for the diagnosis and endoscopic differential diagnosis of NIBD.
Time frame: two year
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 7 Sep 2015.
- Derived from this study: PubMed 27612488Carballal S, Maisterra S, Lopez-Serrano A, Gimeno-Garcia AZ, Vera MI, Marin-Garbriel JC, Diaz-Tasende J, Marquez L, Alvarez MA, Hernandez L, De Castro L, Gordillo J, Puig I, Vega P, Bustamante-Balen M, Acevedo J, Penas B, Lopez-Ceron M, Ricart E, Cuatrecasas M, Jimeno M, Pellise M; EndoCAR group of the Spanish Gastroenterological Association and Spanish Digestive Endoscopy Society. Real-life chromoendoscopy for neoplasia detection and characterisation in long-standing IBD. Gut. 2018 Jan;67(1):70-78. doi: 10.1136/gutjnl-2016-312332. Epub 2016 Sep 9.
Related trials for Inflammatory Bowel Disease
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
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel 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.
Maria Pellise, MDPHD principal investigator
Hospital Clinic of Barcelona
15 sites 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 Disease and Colorectal Cancer, run by Hospital Clinic of Barcelona at 15 sites in Spain.
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 7 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: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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?
Prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain (time frame: two year). 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 NCT02543762, 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 7 Sep 2015.