Impact of Methylation Alterations in Colon Cancer: Epidemiology and Prognosis

NCT01904968 | Withdrawn

• 1 other identifier: Piard PHRC K 2011
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (4)

• Quality control DNA

  at baseline

• Assessment of methylation level

  at the baseline

• MSI Phenotype evaluation

  at the baseline

• Mutational status evaluation of BRAF, KRAS and PI3KCA :

  at the baseline

Study Arms (1)

Colon cancers in patients living the Cote D'or area

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Colon cancers in patients living the Cote D'or area

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de Dijon

Dijon, 21079, France

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Françoise PIARD

  CHU Dijon /INSERM U866

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 22, 2013
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2022
• Last Updated: March 29, 2024

Record last verified: 2013-07

Locations

FR (1)