Ignite Creation Date:
2024-05-06 @ 1:49 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01904968
Status:
WITHDRAWN
Last Update Posted:
2024-03-29
First Post:
2013-06-26
Brief Title:
Impact of Methylation Alterations in Colon Cancer Epidemiology and Prognosis
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
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:
None
Brief Summary:
We conducted a preliminary study in 2010 using the innovative Illumina GoldenGate methylation assay which has enabled us to characterize the level of methylation of 807 potential markers on a series of 200 adenocarcinomas of the colon C18 and rectosigmoid junction C19 resected between 1998 and 2001 The results validated by pyrosequencing allowed us to establish a panel of 12 markers to assess the level of methylation The aim of this project is to validate the prognostic value of this panel in a second cohort of patients with adenocarcinomas stage I to IV resected between 2002 and 2006 in public and private hospitals n685
This study relies on an original collection of surgical specimens of colorectal cancers resected in public and private hospitals among patients resident in the département of Côte-dOr and followed by the cancer registry of Burgundy Samples obtained from each cancer and from adjacent normal mucosa are stored in liquid nitrogen in the Ferdinand Cabane Biological Resources Centrecertified S 96900 Annotations are collected by the cancer registry staff from multiple sources pathologists gastroenterologists oncologists and radiotherapists
Pyrosequencing will be used to quantify the level of methylation The percentage of methylated allele for each marker on cancerous DNA and the ratio of methylated markers to the number of markers analyzed will be determined The molecular status of MSI BRAF KRAS and PI3K will be taken into consideration
To study the prognosis relative and relapse free-survival will be calculated A multivariate relative survival analysis will be performed to determine independent prognostic factors taking into account the characteristics of patients and tumours and epigenetic and molecular alterations Epigenetic alterations will be described according to age group sex and subsite The epigenetic phenotypes will be evaluated according to already known molecular status using logistic regression models
This study relies on an original collection of surgical specimens of colorectal cancers resected in public and private hospitals among patients resident in the département of Côte-dOr and followed by the cancer registry of Burgundy Samples obtained from each cancer and from adjacent normal mucosa are stored in liquid nitrogen in the Ferdinand Cabane Biological Resources Centrecertified S 96900 Annotations are collected by the cancer registry staff from multiple sources pathologists gastroenterologists oncologists and radiotherapists
Pyrosequencing will be used to quantify the level of methylation The percentage of methylated allele for each marker on cancerous DNA and the ratio of methylated markers to the number of markers analyzed will be determined The molecular status of MSI BRAF KRAS and PI3K will be taken into consideration
To study the prognosis relative and relapse free-survival will be calculated A multivariate relative survival analysis will be performed to determine independent prognostic factors taking into account the characteristics of patients and tumours and epigenetic and molecular alterations Epigenetic alterations will be described according to age group sex and subsite The epigenetic phenotypes will be evaluated according to already known molecular status using logistic regression models
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None