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
  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 endometrial cancer.


Condition Intervention
Endometrial 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 Endometrial Cancer in East Anglia, Oxford Trent and West Midlands

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 ]
  • 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 ]

Estimated Enrollment: 2000
Study Start Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758056

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: NCT00758056     History of Changes
Other Study ID Numbers: CDR0000598877, MREC-SEARCH-ENDOMETRIAL, 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):
endometrial cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on April 17, 2014