Ignite Creation Date:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT02878395
Status:
UNKNOWN
Last Update Posted:
2016-08-25
First Post:
2016-08-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases: Prediction of Post-operating Natural History of Crohn's Disease
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDIPOSTOP
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: