Ignite Creation Date:
2025-12-17 @ 8:14 PM
Ignite Modification Date:
2025-12-18 @ 1:18 AM
Study NCT ID:
NCT00757211
Status:
None
Last Update Posted:
2013-08-26 00:00:00
First Post:
2008-09-22 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Genes and Environment in Patients With Breast Cancer in the East Anglia Region of the United Kingdom
Sponsor:
None
Organization:
Study Overview
Official Title:
A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Breast Cancer in East Anglia
Status:
None
Status Verified Date:
2008-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: