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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00757965
First received: September 22, 2008
Last updated: August 23, 2013
Last verified: September 2008
  Purpose

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.


Condition Intervention
Colorectal Cancer
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: questionnaire administration

Study Type: Observational
Official Title: A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Colorectal Cancer in East Anglia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Acquisition of epidemiological information and biological material [ Designated as safety issue: No ]
  • Proportion of colorectal cancer incidence attributable to mutations in known predisposing genes (e.g., MLH1 and MSH2) [ Designated as safety issue: No ]
  • Exploration of mutations at other loci that may predispose to endometrial cancer [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: February 2008
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757965

Locations
United Kingdom
University of Cambridge Cancer Research UK Recruiting
Cambridge, England, United Kingdom, CB1 8RN
Contact: Contact Person    44-122-374-0166    paul.pharoah@srl.cam.ac.uk   
Sponsors and Collaborators
Cancer Research UK
Investigators
Study Chair: Paul Pharoah, MD Cancer Research UK
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00757965     History of Changes
Other Study ID Numbers: CDR0000598882, MREC-SEARCH-COLORECTAL, MREC-07/MRE05/17
Study First Received: September 22, 2008
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014