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

Endometrial Cancer Clinical Trial

Official title:

A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Endometrial Cancer in East Anglia, Oxford Trent and West Midlands

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00758056
• Other study ID #: CDR0000598877
• Secondary ID: MREC-SEARCH-ENDO
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2008
• Last updated: August 23, 2013
• Start date: February 2008

Study information

• Verified date: September 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 74 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Genetic:
• polymorphism analysis

Other:
• laboratory biomarker analysis

• questionnaire administration

Locations

Country	Name	City	State
United Kingdom	University of Cambridge Cancer Research UK	Cambridge	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition of epidemiological information and biological material			No
Primary	The prevalence of endometrial cancer attributable to mutations in known predisposing genes such as MSH2 and MLH1			No
Primary	Determination of risk associated with these predisposing mutations by examining the cancer risk in relatives of patients who are shown to be carriers			No
Primary	Examination of the effect of nongenetic risk factors in mutation carriers			No
Primary	The pathological and clinical characteristics of endometrial cancers occurring in mutation carriers as compared with that in noncarriers			No
Primary	Exploration of mutations at other loci that may predispose to endometrial cancer			No