- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00758056
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
A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Endometrial Cancer in East Anglia, Oxford Trent and West Midlands
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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England
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Cambridge, England, United Kingdom, CB1 8RN
- Recruiting
- University of Cambridge Cancer Research UK
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Contact:
- Contact Person
- Phone Number: 44-122-374-0166
- Email: paul.pharoah@srl.cam.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Acquisition of epidemiological information and biological material
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Exploration of mutations at other loci that may predispose to endometrial cancer
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The prevalence of endometrial cancer attributable to mutations in known predisposing genes such as MSH2 and MLH1
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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
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The pathological and clinical characteristics of endometrial cancers occurring in mutation carriers as compared with that in noncarriers
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Paul Pharoah, MD, Cancer Research UK
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000598877
- MREC-07/MRE05/17
- MREC-SEARCH-ENDOMETRIAL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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