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

Crohn Disease Clinical Trial

— PREDIPOSTOP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02878395
• Other study ID #: PJC 2014/MICI-GERMAIN/MS
• Status: Not yet recruiting
• Phase: N/A
• First received: August 22, 2016
• Last updated: August 22, 2016
• Start date: September 2016
• Est. completion date: January 2021

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: Adeline GERMAIN
• Email: a.germain[@]chru-nancy.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Procedure:
• Ileocolic resection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression profile in intestinal operative specimens		up to 2 months (from resection)	No
Primary	Methylation profile in intestinal operative specimens		up to 2 months (from resection)	No
Secondary	Digestive symptoms	such as abdominal pain, Koenig syndrome (abdominal pain relieved by flatus or feces expulsion), diarrhea	6, 12, 24 months (after resection)	No
Secondary	Radiological classification of recurrence with entero-MRI performed for post-operating follow-up of patients	Koilakou score, recurrence when score >=1	6, 12, 24 months (after resection)	No
Secondary	Evaluation of recurrence with endoscopy performed for post-operating follow-up of patients	Rutgeerts criteria (recurrence when score >=i1)	6, 12, 24 months (after resection)	No