Study of Genes and the Environment in Patients With Endometrial Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom
Primary Purpose
Endometrial Cancer
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
polymorphism analysis
laboratory biomarker analysis
questionnaire administration
Sponsored by
About this trial
This is an observational trial for Endometrial Cancer focused on measuring endometrial cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of endometrial cancer within the past 5 years
Identified in any of the following geographic regions of the United Kingdom:
- East Anglia
- Oxford
- Trent
- West Midlands
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
Sites / Locations
- University of Cambridge Cancer Research UKRecruiting
Outcomes
Primary Outcome Measures
Acquisition of epidemiological information and biological material
The prevalence of endometrial cancer attributable to mutations in known predisposing genes such as MSH2 and MLH1
Determination of risk associated with these predisposing mutations by examining the cancer risk in relatives of patients who are shown to be carriers
Examination of the effect of nongenetic risk factors in mutation carriers
The pathological and clinical characteristics of endometrial cancers occurring in mutation carriers as compared with that in noncarriers
Exploration of mutations at other loci that may predispose to endometrial cancer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00758056
Brief Title
Study of Genes and the Environment in Patients With Endometrial Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom
Official Title
A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Endometrial Cancer in East Anglia, Oxford Trent and West Midlands
Study Type
Observational
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cancer Research UK
4. Oversight
5. Study Description
Brief 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 to cancer and interactions between genes and the environment in patients with endometrial cancer.
Detailed Description
OBJECTIVES:
To obtain epidemiological information and biological material on a population-based series of endometrial cancer cases.
To define the proportion of endometrial cancer incidence attributable to mutations in known predisposing genes such as MSH2 and MLH1.
To determine the risk associated with these predisposing mutations by examining the cancer risk in relatives of patients who are shown to be carriers.
To examine the effect of nongenetic risk factors in mutation carriers.
To determine the pathological and clinical characteristics of endometrial cancers occurring in mutation carriers as compared with that in noncarriers.
To establish whether mutations at other loci may predispose to endometrial cancer by comparing the frequency of alterations in endometrial 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 will request identifying information about the patient's first-degree relatives.
Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as 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 endometrial 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 in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
endometrial cancer
7. Study Design
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Acquisition of epidemiological information and biological material
Title
The prevalence of endometrial cancer attributable to mutations in known predisposing genes such as MSH2 and MLH1
Title
Determination of risk associated with these predisposing mutations by examining the cancer risk in relatives of patients who are shown to be carriers
Title
Examination of the effect of nongenetic risk factors in mutation carriers
Title
The pathological and clinical characteristics of endometrial cancers occurring in mutation carriers as compared with that in noncarriers
Title
Exploration of mutations at other loci that may predispose to endometrial cancer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of endometrial cancer within the past 5 years
Identified in any of the following geographic regions of the United Kingdom:
East Anglia
Oxford
Trent
West Midlands
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Pharoah, MD
Organizational Affiliation
Cancer Research UK
Official's Role
Study Chair
Facility Information:
Facility Name
University of Cambridge Cancer Research UK
City
Cambridge
State/Province
England
ZIP/Postal Code
CB1 8RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-122-374-0166
Email
paul.pharoah@srl.cam.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Study of Genes and the Environment in Patients With Endometrial Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom
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