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

NCT ID: NCT00757263

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Keywords

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ovarian epithelial cancer ovarian germ cell tumor ovarian sarcoma ovarian stromal cancer

Interventions

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polymorphism analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role lead

Principal Investigators

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Paul Pharoah, MD

Role: STUDY_CHAIR

Cancer Research UK

Locations

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University of Cambridge Cancer Research UK

Cambridge, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Contact Person

Role: primary

Other Identifiers

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MREC-SEARCH-OVARIAN

Identifier Type: -

Identifier Source: secondary_id

MREC-07/MRE05/17

Identifier Type: -

Identifier Source: secondary_id

CDR0000598881

Identifier Type: -

Identifier Source: org_study_id