Study of Genes and the Environment in Patients With Colorectal Cancer in the East Anglia Region of the United Kingdom

Colorectal Cancer Clinical Trial

Official title:

A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Colorectal Cancer in East Anglia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00757965
• Other study ID #: CDR0000598882
• Secondary ID: MREC-SEARCH-COLO
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2008
• Last updated: August 23, 2013
• Start date: February 2008

Study information

• Verified date: September 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between genes and the environment in patients with colorectal cancer.

Description:

OBJECTIVES:

• To obtain epidemiological information and biological material on a population based series of colorectal cancer cases.

• To define the proportion of colorectal cancer incidence attributable to mutations in known predisposing genes such as MLH1 and MSH2.

• To establish whether mutations at other loci may predispose to colorectal cancer, by comparing the frequency of alteration candidate genes in colorectal cancer patients with the corresponding frequency in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.

OUTLINE: This is a multicenter study.

Patients complete an epidemiological questionnaire. The questionnaire also requests identifying information about the patient's first-degree relatives.

Blood samples are collected from patients. DNA is extracted from these blood samples, from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL, and from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population-based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.

In addition to the colorectal cancer patients recruited for this study, patients with breast, ovarian, prostate, colorectal, bladder, kidney, pancreatic, brain, and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited for the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-ENDOMETRIAL, and MREC-SEARCH-CANCER.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of colorectal cancer within the past 5 years

• Identified in the East Anglia region of the United Kingdom

PATIENT CHARACTERISTICS:

• Identified by the patient's general practitioner as fit to contact for this study

• No serious mental illness or retardation

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

N/A

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Genetic:
• polymorphism analysis

Other:
• laboratory biomarker analysis

• questionnaire administration

Locations

Country	Name	City	State
United Kingdom	University of Cambridge Cancer Research UK	Cambridge	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition of epidemiological information and biological material			No
Primary	Proportion of colorectal cancer incidence attributable to mutations in known predisposing genes (e.g., MLH1 and MSH2)			No
Primary	Exploration of mutations at other loci that may predispose to endometrial cancer			No