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Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases

Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases: Prediction of Post-operating Natural History of Crohn's Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02878395
Acronym
PREDIPOSTOP
Enrollment
30
Registered
2016-08-25
Start date
2016-09-30
Completion date
2021-01-31
Last updated
2016-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

genomics, epigenomics, recurrence

Brief summary

The purpose is to search for enterocyte-specific or non-specific molecular signature of post-operating recurrence of Crohn's disease in transcriptome (measurement of gene expression through number of mRNA copies transcribed for each gene) and in methylome. Secondary objectives are to compare expression and methylation profiles according to: * treatment response * morphological (endoscopic and/or radiological) and clinical post-operating recurrence.

Detailed description

This aim of this study is to search for new biomarkers predictive of post-operating recurrence. At present, there are no biomarkers predictive for post-operating recurrence and administration of a post-operating medical treatment to prevent recurrence is based on biological, endoscopic and imagery data. Predictive biomarkers could allow the identification of patients with high risk of post-operating recurrence and administration of a systematic prophylactic post-operating treatment and at the same time avoiding the prescription of this treatment to patients with low risk of post-operating recurrence.

Interventions

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient with inflammatory bowel disease diagnosis based on clinical (abdominal pain, diarrhea and/or dysenteric syndrome, mostly muco-hemorrhagic, perianal injury, with sometimes general signs and /or systemic manifestations ), biological (inflammatory syndrome, deficiencies…), radiological (entero-MRI), endoscopic (presence of granulomatous lesions) and/or histological (epithelioid and giant cellular granuloma) data * Patient undergoing ileocolic resection * Patient affiliated to French social security

Exclusion criteria

* Patient refusing sampling * Patient with undetermined colitis * Patient with non-confirmed diagnosis of inflammatory bowel disease * Patient with inflammatory bowel disease not undergoing ileocolic resection

Design outcomes

Primary

MeasureTime frame
Gene expression profile in intestinal operative specimensup to 2 months (from resection)
Methylation profile in intestinal operative specimensup to 2 months (from resection)

Secondary

MeasureTime frameDescription
Digestive symptoms6, 12, 24 months (after resection)such as abdominal pain, Koenig syndrome (abdominal pain relieved by flatus or feces expulsion), diarrhea
Radiological classification of recurrence with entero-MRI performed for post-operating follow-up of patients6, 12, 24 months (after resection)Koilakou score, recurrence when score \>=1
Evaluation of recurrence with endoscopy performed for post-operating follow-up of patients6, 12, 24 months (after resection)Rutgeerts criteria (recurrence when score \>=i1)

Contacts

Primary ContactAdeline GERMAIN
a.germain@chru-nancy.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026