NCT01180452

Brief Summary

Patients with Crohn's disease (CD) have an increased risk of small bowel adenocarcinoma (SBA). Long duration of CD is the main risk factor. SB dysplasia has been associated with SBA in 20% of cases, always described in diseased sites. The progression to neoplasia and natural history remains unknown but progression of inflammation to dysplasia and then to adenocarcinoma is suspected. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

4.4 years

First QC Date

March 31, 2010

Last Update Submit

June 21, 2015

Conditions

Crohn Disease Located in Jejunum or Ileum

Keywords

Crohn diseasedysplasiaadenocarcinomaendoscopyjejunumileum

Outcome Measures

Primary Outcomes (1)

  • Frequency of dysplasia and adenocarcinoma

    dysplasia will be described as high or low level Samples will be analysed by 2 different team of anapathologists

    2 months

Secondary Outcomes (1)

  • Success of endoscopic detection

    1-3 Months

Study Arms (1)

Single group open label

OTHER

Prospective Cohort

Procedure: enteroscopy

Interventions

enteroscopyPROCEDURE

endoscopic enteroscopy to do biopsies on jejunum

Single group open label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 18-years-old
  • Crohn disease on jejunum and/or ileum since at least 10 years
  • Radiography done during last year

You may not qualify if:

  • Dysplasia previously detected
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Chu Amiens

Amiens, 80054, France

Location

Chu Besancon

Besançon, 25030, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

Hopital Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Chru Lille

Lille, 59037, France

Location

CHU NICE

Nice, 06202, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Institut Mutualiste Montsouris (Imm)

Paris, 75674, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

CHU LYON

Pierre-Bénite, 69495, France

Location

Chu Rouen

Rouen, 76031, France

Location

Chu Saint Etienne

Saint-Etienne, 42270, France

Location

Chu Toulouse

Toulouse, 31403, France

Location

Chu Tours

Tours, 37044, France

Location

Chu Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (14)

  • 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.

    PMID: 12432298RESULT

  • 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.

    PMID: 17308939RESULT

  • 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.

    PMID: 16393226RESULT

  • 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.

    PMID: 16611269RESULT

  • 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.

    PMID: 16116317RESULT

  • 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.

    PMID: 1499440RESULT

  • 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.

    PMID: 15058524RESULT

  • 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.

    PMID: 18564124RESULT

  • 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.

    PMID: 17762967RESULT

  • 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.

    PMID: 623378RESULT

  • 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.

    PMID: 1948581RESULT

  • 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.

    PMID: 17593171RESULT

  • 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.

    PMID: 6629368RESULT

  • 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.

    PMID: 10896917RESULT

Related Links

MeSH Terms

Conditions

Crohn DiseaseAdenocarcinoma

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Marion Simon, Doctor

    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    PRINCIPAL INVESTIGATOR

  • Marc Lémann, PhD

    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    STUDY CHAIR

  • Yoram BOUHNIK, PhD

    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2010

First Posted

August 12, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

FR(15)