NCT00769236

Brief Summary

We propose to study the intestinal secretion of ASCA by evaluating them in biopsy culture supernatants from a cohort of patients suffering from CD (n=80) and a cohort of control patients (UC (n=40) and patients without IBD (n=40 )).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

May 7, 2026

Status Verified

August 1, 2014

Enrollment Period

1.9 years

First QC Date

October 8, 2008

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compare the performances of the dosage of the ASCA in floating it of culture of intestinal biopsies in that of their dosage in the serum

    24 months

Secondary Outcomes (1)

  • Determine if the patients reached by disease of crohn not presenting ASCA in their serum represent one under group of disease of crohn

    24 months

Study Arms (3)

1

OTHER

Patients with crohn disease

Other: Blood sampling and biopsy

2

OTHER

Patients reached by hemorrhagic first side-colitis

Other: Biopsy and blood sampling

3

OTHER

Patients controls

Other: Biopsy and blood sampling

Interventions

Biopsy and blood : Research for various antibodies

1

Biopsy and blood : research for various antibodies

2

Eligibility Criteria

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

You may qualify if:

  • Patients reached by disease of crohn
  • patients reached by hemorrhagic first side-colitis

You may not qualify if:

  • Forms ileales or ano-périneales pure of disease of crohn
  • indefinite colitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire d'Immunologie - Hopital de la Conception

Marseille, 13005, France

Location

Related Publications (1)

  • Bertin D, Grimaud JC, Lesavre N, Benelmouloud C, Desjeux A, Garcia S, Desplat-Jego S. Targeting tissular immune response improves diagnostic performance of anti-Saccharomyces cerevisiae antibodies (ASCA) in Crohn's disease. PLoS One. 2013 Nov 26;8(11):e80433. doi: 10.1371/journal.pone.0080433. eCollection 2013.

MeSH Terms

Conditions

Crohn Disease

Interventions

Blood Specimen CollectionBiopsy

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCytodiagnosisCytological TechniquesDiagnostic Techniques, Surgical

Study Officials

  • Sophie Desplat-Jego, MD

    Assistance Publique des Hopitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

June 1, 2008

Primary Completion

May 1, 2010

Study Completion

August 1, 2010

Last Updated

May 7, 2026

Record last verified: 2014-08

Locations