Endoscopic Detection of Dysplasia in Crohn 's Disease Patient
NCT ID: NCT01180452
Last Updated: 2015-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
107 participants
INTERVENTIONAL
2010-01-31
2014-06-30
Brief Summary
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As for surveillance recommendations for colorectal carcinoma in long standing inflammatory colonic disease, endoscopic screening of SB could be proposed in CD patients with risk factors of SBA. No study can be found in literature.
The investigators propose a multicenter exploratory open study on prospective cohort of CD patients with high risk of dysplasia or cancer. The goal is evaluate the rate of dysplasia and adenocarcinoma detected by enteroscopy with biopsies in a high risk CD population
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single group open label
Prospective Cohort
enteroscopy
endoscopic enteroscopy to do biopsies on jejunum
Interventions
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enteroscopy
endoscopic enteroscopy to do biopsies on jejunum
Eligibility Criteria
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Inclusion Criteria
* Crohn disease on jejunum and/or ileum since at least 10 years
* Radiography done during last year
Exclusion Criteria
* Pregnancy
18 Years
ALL
No
Sponsors
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Principal Investigators
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Marion Simon, Doctor
Role: PRINCIPAL_INVESTIGATOR
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Marc Lémann, PhD
Role: STUDY_CHAIR
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Yoram BOUHNIK, PhD
Role: STUDY_DIRECTOR
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Locations
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Chu Amiens
Amiens, , France
Chu Besancon
Besançon, , France
Hopital Beaujon
Clichy, , France
Hopital Bicetre
Le Kremlin-Bicêtre, , France
Chru Lille
Lille, , France
CHU NICE
Nice, , France
Hopital Saint Louis
Paris, , France
Institut Mutualiste Montsouris (Imm)
Paris, , France
Hopital Haut Leveque
Pessac, , France
CHU LYON
Pierre-Bénite, , France
Chu Rouen
Rouen, , France
Chu Saint Etienne
Saint-Etienne, , France
Chu Toulouse
Toulouse, , France
Chu Tours
Tours, , France
Chu Nancy
Vandœuvre-lès-Nancy, , France
Countries
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References
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Abrahams NA, Halverson A, Fazio VW, Rybicki LA, Goldblum JR. Adenocarcinoma of the small bowel: a study of 37 cases with emphasis on histologic prognostic factors. Dis Colon Rectum. 2002 Nov;45(11):1496-502. doi: 10.1097/01.DCR.0000034134.49346.5E.
von Roon AC, Reese G, Teare J, Constantinides V, Darzi AW, Tekkis PP. The risk of cancer in patients with Crohn's disease. Dis Colon Rectum. 2007 Jun;50(6):839-55. doi: 10.1007/s10350-006-0848-z.
Jess T, Gamborg M, Matzen P, Munkholm P, Sorensen TI. Increased risk of intestinal cancer in Crohn's disease: a meta-analysis of population-based cohort studies. Am J Gastroenterol. 2005 Dec;100(12):2724-9. doi: 10.1111/j.1572-0241.2005.00287.x.
Canavan C, Abrams KR, Mayberry J. Meta-analysis: colorectal and small bowel cancer risk in patients with Crohn's disease. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1097-104. doi: 10.1111/j.1365-2036.2006.02854.x.
Palascak-Juif V, Bouvier AM, Cosnes J, Flourie B, Bouche O, Cadiot G, Lemann M, Bonaz B, Denet C, Marteau P, Gambiez L, Beaugerie L, Faivre J, Carbonnel F. Small bowel adenocarcinoma in patients with Crohn's disease compared with small bowel adenocarcinoma de novo. Inflamm Bowel Dis. 2005 Sep;11(9):828-32. doi: 10.1097/01.mib.0000179211.03650.b6.
Lashner BA. Risk factors for small bowel cancer in Crohn's disease. Dig Dis Sci. 1992 Aug;37(8):1179-84. doi: 10.1007/BF01296557.
Solem CA, Harmsen WS, Zinsmeister AR, Loftus EV Jr. Small intestinal adenocarcinoma in Crohn's disease: a case-control study. Inflamm Bowel Dis. 2004 Jan;10(1):32-5. doi: 10.1097/00054725-200401000-00005.
Piton G, Cosnes J, Monnet E, Beaugerie L, Seksik P, Savoye G, Cadiot G, Flourie B, Capelle P, Marteau P, Lemann M, Colombel JF, Khouri E, Bonaz B, Carbonnel F. Risk factors associated with small bowel adenocarcinoma in Crohn's disease: a case-control study. Am J Gastroenterol. 2008 Jul;103(7):1730-6. doi: 10.1111/j.1572-0241.2008.01847.x. Epub 2008 Jun 28.
Yamamoto T, Fazio VW, Tekkis PP. Safety and efficacy of strictureplasty for Crohn's disease: a systematic review and meta-analysis. Dis Colon Rectum. 2007 Nov;50(11):1968-86. doi: 10.1007/s10350-007-0279-5.
Greenstein AJ, Sachar D, Pucillo A, Kreel I, Geller S, Janowitz HD, Aufses A Jr. Cancer in Crohn's disease after diversionary surgery. A report of seven carcinomas occurring in excluded bowel. Am J Surg. 1978 Jan;135(1):86-90. doi: 10.1016/0002-9610(78)90015-6. No abstract available.
Ribeiro MB, Greenstein AJ, Heimann TM, Yamazaki Y, Aufses AH Jr. Adenocarcinoma of the small intestine in Crohn's disease. Surg Gynecol Obstet. 1991 Nov;173(5):343-9.
Watermeyer G, Locketz M, Govender D, Mall A. Crohn's disease-associated small bowel adenocarcinoma with pre-existing low-grade dysplasia: a case report. Am J Gastroenterol. 2007 Jul;102(7):1545-6. doi: 10.1111/j.1572-0241.2007.01166.x. No abstract available.
Riddell RH, Goldman H, Ransohoff DF, Appelman HD, Fenoglio CM, Haggitt RC, Ahren C, Correa P, Hamilton SR, Morson BC, et al. Dysplasia in inflammatory bowel disease: standardized classification with provisional clinical applications. Hum Pathol. 1983 Nov;14(11):931-68. doi: 10.1016/s0046-8177(83)80175-0.
Schlemper RJ, Riddell RH, Kato Y, Borchard F, Cooper HS, Dawsey SM, Dixon MF, Fenoglio-Preiser CM, Flejou JF, Geboes K, Hattori T, Hirota T, Itabashi M, Iwafuchi M, Iwashita A, Kim YI, Kirchner T, Klimpfinger M, Koike M, Lauwers GY, Lewin KJ, Oberhuber G, Offner F, Price AB, Rubio CA, Shimizu M, Shimoda T, Sipponen P, Solcia E, Stolte M, Watanabe H, Yamabe H. The Vienna classification of gastrointestinal epithelial neoplasia. Gut. 2000 Aug;47(2):251-5. doi: 10.1136/gut.47.2.251.
Related Links
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Related Info
Other Identifiers
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GETAID 2008-4
Identifier Type: -
Identifier Source: org_study_id
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