NCT00783575

Brief Summary

The purpose of this study is to look for the NOD2 gene in children with Inflammatory Bowel Disease (IBD) and their parents. We hope to understand this NOD2 gene better by determining whether children that have IBD have the NOD2 gene. In those with the NOD2 gene, we want to see if the type of gene abnormality predicts the nature of their disease and if the genetic information helps doctors decide what therapies and/or treatments to use for their patients. We also hope to explore the relationships between known serologic markers of IBD (ASCA, pANCA, ompC) and the clinical characteristics and course of children with IBD. About 1500 children and as many of their parents as possible will take part in this study. Children who are newly diagnosed with IBD as well as children that are being seen in the Children's Health System are eligible to participate in this study. We are looking for children 18 years old or younger to participate. If possible, we would also like both parents of the child to participate.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 1, 2002

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

12.3 years

First QC Date

October 29, 2008

Last Update Submit

August 21, 2015

Conditions

Crohn's DiseaseUlcerative ColitisInflammatory Bowel Disease

Keywords

Crohn's diseaseUlcerative colitisInflammatory bowel diseaseNOD2,CARD 15 mutations

Outcome Measures

Primary Outcomes (1)

  • Genotype a cohort of IBD children for 4 NOD2/CARD15 mutations.

    Study completion

Secondary Outcomes (1)

  • Statistical analysis of phenotype and genotype correlation in a cohort of pediatric Inflammatory Bowel Disease children with or without a family history of Inflammatory Bowel Disease

    Study completion

Study Arms (1)

Inflammatory Bowel Disease

Crohn's disease (CD) and ulcerative colitis (UC), collectively known as inflammatory bowel disease (IBD) are chronic, life-long, destructive inflammatory conditions of the gastrointestinal tract.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children from Southeast Wisconsin diagnosed with Inflammatory Bowel Disease at Children's Hospital of Wisconsin and their biological parents.

You may qualify if:

  • Confirmed diagnosis of Inflammatory Bowel Disease (Crohn's Disease, ulcerative colitis or indeterminate colitis).

You may not qualify if:

  • Diagnosis during non-pediatric age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (25)

  • Sawczenko A, Sandhu BK, Logan RF, Jenkins H, Taylor CJ, Mian S, Lynn R. Prospective survey of childhood inflammatory bowel disease in the British Isles. Lancet. 2001 Apr 7;357(9262):1093-4. doi: 10.1016/s0140-6736(00)04309-9.

    PMID: 11297962BACKGROUND

  • Orchard TR, Satsangi J, Van Heel D, Jewell DP. Genetics of inflammatory bowel disease: a reappraisal. Scand J Immunol. 2000 Jan;51(1):10-7. doi: 10.1046/j.1365-3083.2000.00656.x.

    PMID: 10632970BACKGROUND

  • Ahmad T, Armuzzi A, Bunce M, Mulcahy-Hawes K, Marshall SE, Orchard TR, Crawshaw J, Large O, de Silva A, Cook JT, Barnardo M, Cullen S, Welsh KI, Jewell DP. The molecular classification of the clinical manifestations of Crohn's disease. Gastroenterology. 2002 Apr;122(4):854-66. doi: 10.1053/gast.2002.32413.

    PMID: 11910336BACKGROUND

  • Podolsky DK. Inflammatory bowel disease (1). N Engl J Med. 1991 Sep 26;325(13):928-37. doi: 10.1056/NEJM199109263251306. No abstract available.

    PMID: 1881418BACKGROUND

  • Podolsky DK. Inflammatory bowel disease (2). N Engl J Med. 1991 Oct 3;325(14):1008-16. doi: 10.1056/NEJM199110033251406. No abstract available.

    PMID: 1886623BACKGROUND

  • Hugot JP, Laurent-Puig P, Gower-Rousseau C, Olson JM, Lee JC, Beaugerie L, Naom I, Dupas JL, Van Gossum A, Orholm M, Bonaiti-Pellie C, Weissenbach J, Mathew CG, Lennard-Jones JE, Cortot A, Colombel JF, Thomas G. Mapping of a susceptibility locus for Crohn's disease on chromosome 16. Nature. 1996 Feb 29;379(6568):821-3. doi: 10.1038/379821a0.

    PMID: 8587604BACKGROUND

  • Hampe, J. and S. Schrieber, A genome-wide search identies potential susceptibility loci for Crohn's disease. Am J Hum Genet, 1999. 64: p. 808-16.

    BACKGROUND

  • Hugot JP, Chamaillard M, Zouali H, Lesage S, Cezard JP, Belaiche J, Almer S, Tysk C, O'Morain CA, Gassull M, Binder V, Finkel Y, Cortot A, Modigliani R, Laurent-Puig P, Gower-Rousseau C, Macry J, Colombel JF, Sahbatou M, Thomas G. Association of NOD2 leucine-rich repeat variants with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):599-603. doi: 10.1038/35079107.

    PMID: 11385576BACKGROUND

  • Ogura Y, Bonen DK, Inohara N, Nicolae DL, Chen FF, Ramos R, Britton H, Moran T, Karaliuskas R, Duerr RH, Achkar JP, Brant SR, Bayless TM, Kirschner BS, Hanauer SB, Nunez G, Cho JH. A frameshift mutation in NOD2 associated with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):603-6. doi: 10.1038/35079114.

    PMID: 11385577BACKGROUND

  • Calkins, B.M., Inflammatory Bowel Diseases, in Digestive Diseases in the United States: Epidemiology and Impact, J.E. Everhart, Editor. 1994, U.S. Government Printing Office: Washington D.C. p. 509-550.

    BACKGROUND

  • Sandborn WJ. A review of immune modifier therapy for inflammatory bowel disease: azathioprine, 6-mercaptopurine, cyclosporine, and methotrexate. Am J Gastroenterol. 1996 Mar;91(3):423-33. No abstract available.

    PMID: 8633486BACKGROUND

  • D'Haens GR, Gasparaitis AE, Hanauer SB. Duration of recurrent ileitis after ileocolonic resection correlates with presurgical extent of Crohn's disease. Gut. 1995 May;36(5):715-7. doi: 10.1136/gut.36.5.715.

    PMID: 7797122BACKGROUND

  • Loftus EV Jr, Schoenfeld P, Sandborn WJ. The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther. 2002 Jan;16(1):51-60. doi: 10.1046/j.1365-2036.2002.01140.x.

    PMID: 11856078BACKGROUND

  • Barton JR, Gillon S, Ferguson A. Incidence of inflammatory bowel disease in Scottish children between 1968 and 1983; marginal fall in ulcerative colitis, three-fold rise in Crohn's disease. Gut. 1989 May;30(5):618-22. doi: 10.1136/gut.30.5.618.

    PMID: 2786488BACKGROUND

  • Cosgrove M, Al-Atia RF, Jenkins HR. The epidemiology of paediatric inflammatory bowel disease. Arch Dis Child. 1996 May;74(5):460-1. doi: 10.1136/adc.74.5.460.

    PMID: 8669968BACKGROUND

  • Armitage E, Drummond H, Ghosh S, Ferguson A. Incidence of juvenile-onset Crohn's disease in Scotland. Lancet. 1999 May 1;353(9163):1496-7. doi: 10.1016/S0140-6736(99)00333-5. No abstract available.

    PMID: 10232323BACKGROUND

  • Satsangi J, Parkes M, Louis E, Hashimoto L, Kato N, Welsh K, Terwilliger JD, Lathrop GM, Bell JI, Jewell DP. Two stage genome-wide search in inflammatory bowel disease provides evidence for susceptibility loci on chromosomes 3, 7 and 12. Nat Genet. 1996 Oct;14(2):199-202. doi: 10.1038/ng1096-199.

    PMID: 8841195BACKGROUND

  • Forabosco P, Collins A, Latiano A, Annese V, Clementi M, Andriulli A, Fortina P, Devoto M, Morton NE. Combined segregation and linkage analysis of inflammatory bowel disease in the IBD1 region using severity to characterise Crohn's disease and ulcerative colitis. On behalf of the GISC. Eur J Hum Genet. 2000 Nov;8(11):846-52. doi: 10.1038/sj.ejhg.5200542.

    PMID: 11093274BACKGROUND

  • Orholm M, Iselius L, Sorensen TI, Munkholm P, Langholz E, Binder V. Investigation of inheritance of chronic inflammatory bowel diseases by complex segregation analysis. BMJ. 1993 Jan 2;306(6869):20-4. doi: 10.1136/bmj.306.6869.20.

    PMID: 8435571BACKGROUND

  • Monsen U, Iselius L, Johansson C, Hellers G. Evidence for a major additive gene in ulcerative colitis. Clin Genet. 1989 Dec;36(6):411-4.

    PMID: 2591066BACKGROUND

  • Spielman RS, Ewens WJ. The TDT and other family-based tests for linkage disequilibrium and association. Am J Hum Genet. 1996 Nov;59(5):983-9. No abstract available.

    PMID: 8900224BACKGROUND

  • Cho JH, Nicolae DL, Gold LH, Fields CT, LaBuda MC, Rohal PM, Pickles MR, Qin L, Fu Y, Mann JS, Kirschner BS, Jabs EW, Weber J, Hanauer SB, Bayless TM, Brant SR. Identification of novel susceptibility loci for inflammatory bowel disease on chromosomes 1p, 3q, and 4q: evidence for epistasis between 1p and IBD1. Proc Natl Acad Sci U S A. 1998 Jun 23;95(13):7502-7. doi: 10.1073/pnas.95.13.7502.

    PMID: 9636179BACKGROUND

  • Rioux JD, Silverberg MS, Daly MJ, Steinhart AH, McLeod RS, Griffiths AM, Green T, Brettin TS, Stone V, Bull SB, Bitton A, Williams CN, Greenberg GR, Cohen Z, Lander ES, Hudson TJ, Siminovitch KA. Genomewide search in Canadian families with inflammatory bowel disease reveals two novel susceptibility loci. Am J Hum Genet. 2000 Jun;66(6):1863-70. doi: 10.1086/302913. Epub 2000 Apr 21.

    PMID: 10777714BACKGROUND

  • Rioux JD, Daly MJ, Silverberg MS, Lindblad K, Steinhart H, Cohen Z, Delmonte T, Kocher K, Miller K, Guschwan S, Kulbokas EJ, O'Leary S, Winchester E, Dewar K, Green T, Stone V, Chow C, Cohen A, Langelier D, Lapointe G, Gaudet D, Faith J, Branco N, Bull SB, McLeod RS, Griffiths AM, Bitton A, Greenberg GR, Lander ES, Siminovitch KA, Hudson TJ. Genetic variation in the 5q31 cytokine gene cluster confers susceptibility to Crohn disease. Nat Genet. 2001 Oct;29(2):223-8. doi: 10.1038/ng1001-223.

    PMID: 11586304BACKGROUND

  • Lesage S, Zouali H, Cezard JP, Colombel JF, Belaiche J, Almer S, Tysk C, O'Morain C, Gassull M, Binder V, Finkel Y, Modigliani R, Gower-Rousseau C, Macry J, Merlin F, Chamaillard M, Jannot AS, Thomas G, Hugot JP; EPWG-IBD Group; EPIMAD Group; GETAID Group. CARD15/NOD2 mutational analysis and genotype-phenotype correlation in 612 patients with inflammatory bowel disease. Am J Hum Genet. 2002 Apr;70(4):845-57. doi: 10.1086/339432. Epub 2002 Mar 1.

    PMID: 11875755BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA extraction, serology

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Michael C Stephens, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2008

First Posted

October 31, 2008

Study Start

October 1, 2002

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

US(1)