Study of Genes and the Environment in Patients With Ovarian Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00757263
• Other study ID #: CDR0000598881
• Secondary ID: MREC-SEARCH-OVAR
• 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 for cancer and interactions between genes and the environment in patients with ovarian cancer.

Description:

OBJECTIVES:

• To obtain epidemiological information and biological material on a population-based series of ovarian cases.

• To define the proportion of ovarian cancer incidence attributable to mutations in known predisposing genes (e.g., BRCA1 and BRCA2).

• To determine the risk associated with predisposing mutations by examining the cancer risks 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 ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers.

• To establish whether mutations at other loci may predispose to ovarian cancer by comparing the frequency of alterations in ovarian cancer patients with that 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 on 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 ovarian cancer patients recruited for this study, patients with breast, endometrial, 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-ENDOMETRIAL, MREC-SEARCH-PROSTATE, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Recruitment information / eligibility

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

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of ovarian cancer within the past 5 years

• Identified through the East Anglia, Stoke and West Midlands Cancer Registries serving 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

• Ovarian Cancer
• Ovarian 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	Proportion of ovarian cancer incidence attributable to mutations in known predisposing genes (e.g., BRCA1 and BRCA2)			No
Primary	Risk associated with predisposing mutations			No
Primary	Effect of nongenetic risk factors in mutation carriers			No
Primary	Pathological and clinical characteristics of ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers			No
Primary	Exploration of mutations at other loci that may predispose to ovarian cancer			No