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

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:
NCT00758056
First received: September 22, 2008
Last updated: August 23, 2013
Last verified: September 2008

September 22, 2008
August 23, 2013
February 2008
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  • Acquisition of epidemiological information and biological material [ Designated as safety issue: No ]
  • The prevalence of endometrial cancer attributable to mutations in known predisposing genes such as MSH2 and MLH1 [ Designated as safety issue: No ]
  • Determination of risk associated with these predisposing mutations by examining the cancer risk in relatives of patients who are shown to be carriers [ Designated as safety issue: No ]
  • Examination of the effect of nongenetic risk factors in mutation carriers [ Designated as safety issue: No ]
  • The pathological and clinical characteristics of endometrial cancers occurring in mutation carriers as compared with that in noncarriers [ Designated as safety issue: No ]
  • Exploration of mutations at other loci that may predispose to endometrial cancer [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00758056 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
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Endometrial Cancer
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
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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
Female
18 Years to 74 Years
No
United Kingdom
 
NCT00758056
CDR0000598877, MREC-SEARCH-ENDOMETRIAL, MREC-07/MRE05/17
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Cancer Research UK
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Study Chair: Paul Pharoah, MD Cancer Research UK
National Cancer Institute (NCI)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP