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Impact of Methylation Alterations in Colon Cancer: Epidemiology and Prognosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904968
Recruitment Status : Withdrawn
First Posted : July 22, 2013
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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 (n=685).

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-d'Or 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 Centre(certified 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.


Condition or disease
Colon Cancer

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : December 2011
Estimated Primary Completion Date : December 2015

Group/Cohort
Colon cancers in patients living the Cote D'or area



Primary Outcome Measures :
  1. Quality control DNA [ Time Frame: at baseline ]
  2. Assessment of methylation level [ Time Frame: at the baseline ]
  3. MSI Phenotype evaluation [ Time Frame: at the baseline ]
  4. Mutational status evaluation of BRAF, KRAS and PI3KCA : [ Time Frame: at the baseline ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Colon cancers in patients living the Cote D'or area
Criteria

Inclusion Criteria:

  • Adenocarcinomas of the colon (C18) and rectosigmoid junction (C19)
  • Resident in Côte-d'Or
  • Treated by surgical resection

Exclusion Criteria:

  • Rectal cancer
  • Cancer on Crohn's disease and ulcerate colitis
  • Hereditary colon cancer (HNPCC, familial polyposis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904968


Locations
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France
CHU de Dijon
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
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Principal Investigator: Françoise PIARD CHU Dijon /INSERM U866
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01904968    
Other Study ID Numbers: Piard PHRC K 2011
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases