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Crohn Disease Located in Jejunum or IleumPhase 4DYDJINCT01180452

Endoscopic Detection of Dysplasia in Crohn 's Disease Patient

A Phase 4 study testing enteroscopy in people with Crohn Disease Located in Jejunum or Ileum, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
enteroscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
15 sitesFrance
Study dates
Jan 2010to Jun 2014
Phase
Phase 4
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

Who may be able to join

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

Who cannot join

  • Dysplasia previously detected
  • Pregnancy

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Chu Amiens

    Amiens, 80054

  • Chu Besancon

    Besançon, 25030

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Bicetre

    Le Kremlin-Bicêtre, 94275

  • Chru Lille

    Lille, 59037

  • CHU NICE

    Nice, 06202

  • Hopital Saint Louis

    Paris, 75010

  • Institut Mutualiste Montsouris (Imm)

    Paris, 75674

  • Hopital Haut Leveque

    Pessac, 33604

  • CHU LYON

    Pierre-Bénite, 69495

  • Chu Rouen

    Rouen, 76031

  • Chu Saint Etienne

    Saint-Etienne, 42270

  • Chu Toulouse

    Toulouse, 31403

  • Chu Tours

    Tours, 37044

  • Chu Nancy

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: Endoscopic Detection of Small Bowel Dysplasia and Cancer in Patients With Jejuna or Ileal Crohn Disease : Prospective Study in a Cohort of High Risk Patients

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

Being tested
enteroscopy
Keywords
Crohn disease, dysplasia, adenocarcinoma, endoscopy, jejunum, ileum
Medical subject headings
Crohn Disease, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • enteroscopyProcedure or surgery

    endoscopic enteroscopy to do biopsies on jejunum

Study groups in NCT01180452
Study groupRoleWhat they receive
Single group open labelOtherProspective Cohort
Receives: Procedure: enteroscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 months

Secondary outcomes (1)

  1. Success of endoscopic detection

    the success will be measured by reaching at least one pathologic area during the endoscopic procedure

    Measured: 1-3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01180452
Sponsor's protocol ID
GETAID 2008-4
Acronym
DYDJI
Status last verified
Jun 2015
First submitted
31 Mar 2010
Last updated
23 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12432298

  • 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.

    PubMed 17308939

  • 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.

    PubMed 16393226

  • 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.

    PubMed 16611269

  • 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.

    PubMed 16116317

  • 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.

    PubMed 1499440

  • 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.

    PubMed 15058524

  • 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.

    PubMed 18564124

  • 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.

    PubMed 17762967

  • 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.

    PubMed 623378

  • 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.

    PubMed 1948581

  • 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.

    PubMed 17593171

  • 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.

    PubMed 6629368

  • 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.

    PubMed 10896917

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing enteroscopy in people with Crohn Disease Located in Jejunum or Ileum, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 15 sites 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 3 inclusion and 2 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 23 Jun 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 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Frequency of dysplasia and adenocarcinoma (time frame: 2 months). 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 NCT01180452, which also lists 14 linked publications.

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 23 Jun 2015.

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