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Trial record 28 of 4077 for:    colon cancer AND Intestinal Neoplasms

Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease (CE)

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ClinicalTrials.gov Identifier: NCT02543762
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
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
Complexo Hospitalario Universitario de Vigo
Hospital Universitario Doctor Peset
Information provided by (Responsible Party):
Maria Lopez Ceron, Hospital Clinic of Barcelona

Brief Summary:
To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted biopsies

Condition or disease Intervention/treatment
Inflammatory Bowel Disease Colorectal Cancer Procedure: Chromoendoscopy

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease
Study Start Date : February 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

Procedure: Chromoendoscopy
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Usefulness of advanced endoscopy in displasia characterization (chromoendoscopy ) for the diagnosis and endoscopic differential diagnosis of NIBD. [ Time Frame: two year ]
    see title



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospective, multicenter, multicenter study, coordinated by the Department of Gastroenterology, Hospital Clínic of Barcelona
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Personal history of CRC
  • colectomy
  • coagulopathy
  • refusal to participate in the study
  • known allergy to indigo carmine
  • colonoscopy in the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543762


Locations
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Spain
Hospital Sant Jaume de Calella
Calella, Barcelona, Spain
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Manresa
Manresa, Barcelona, Spain, 08240
Hospital general de Mostoles
Mostoles, Madrid, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Pontevedra, Spain, 32005
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain
Gastroenteroly Department, Hospital Clinic
Barcelona, Spain, 08036
Hospital de Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Puerta del Hierro
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Universitario de Canarias
Tenerife, Spain
Hospital de la Fe
Valencia, Spain
Hospital Peset
Valencia, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
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
Complexo Hospitalario Universitario de Vigo
Hospital Universitario Doctor Peset
Investigators
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Principal Investigator: Maria Pellise, MDPHD Hospital Clinic of Barcelona

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Lopez Ceron, MDPHD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02543762     History of Changes
Other Study ID Numbers: 3-Ceron
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: September 2015

Keywords provided by Maria Lopez Ceron, Hospital Clinic of Barcelona:
Chromoendoscopy
Ulcerative Colitis
Crohn disease
Colorectal Neoplasia

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Gastroenteritis