Clinical trial NCT00757263: 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
Official title: A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Ovarian Cancer in East Anglia, Oxford, Trent and West Midlands
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: ovarian epithelial cancer
ovarian germ cell tumor
ovarian sarcoma
ovarian stromal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-09-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Acquisition of epidemiological information and biological material
measure: Proportion of ovarian cancer incidence attributable to mutations in known predisposing genes (e.g., BRCA1 and BRCA2)
measure: Risk associated with predisposing mutations
measure: Effect of nongenetic risk factors in mutation carriers
measure: Pathological and clinical characteristics of ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers
measure: Exploration of mutations at other loci that may predispose to ovarian cancer
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: University of Cambridge Cancer Research UK
state: England
Study officials:
affiliation: Cancer Research UK
name: Paul Pharoah, MD
role: STUDY_CHAIR
References: