Study of Genes and Environment in Patients With Breast 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:
NCT00757211
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 to cancer and interactions between genes and the environment in patients with breast cancer.


Condition Intervention
Breast 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 Breast 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 ]
  • Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of breast cancer [ Designated as safety issue: No ]
  • Proportion of breast cancer incidence attributable to mutations in such genes [ Designated as safety issue: No ]
  • Examination of the interactions between genetic and nongenetic risk factors [ Designated as safety issue: No ]
  • Evaluation of the relationship between pathological and clinical characteristics of breast cancers and germline genotype [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: February 2008
Detailed Description:

OBJECTIVES:

  • To obtain epidemiological information and biological material on a population-based series of breast cancer cases.
  • To establish whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of breast cancer by comparing the frequency of alterations in breast cancer patients with the corresponding frequency in controls.
  • To define the proportion of breast cancer incidence attributable to mutations in such genes.
  • To examine the interactions between genetic and nongenetic risk factors.
  • To evaluate the relationship between pathological and clinical characteristics of breast cancers and germline genotype.

OUTLINE: This is a multicenter study.

Patients complete an epidemiological questionnaire that covers standard known breast cancer risk factors including reproductive history, oral contraceptive use, hormone replacement therapy use, family history, and alcohol consumption. The questionnaire will also request identifying information on 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 breast cancer patients recruited for this study, patients with malignant melanoma and lymphoma, colorectal, ovarian, prostate, colorectal, bladder, kidney, pancreatic, and esophageal cancer, and brain tumors are recruited for the following related clinical trials: MREC-SEARCH-COLORECTAL, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-ENDOMETRIAL, and MREC-SEARCH-CANCER.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer within the past 5 years
  • Identified through the East Anglian Cancer Registry in the East Anglia region of the United Kingdom
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757211

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: NCT00757211     History of Changes
Other Study ID Numbers: CDR0000598878, MREC-SEARCH-BREAST, 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):
breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014