NCT00757263

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
Last Updated

August 26, 2013

Status Verified

September 1, 2008

First QC Date

September 22, 2008

Last Update Submit

August 23, 2013

Conditions

Ovarian Cancer

Keywords

ovarian epithelial cancerovarian germ cell tumorovarian sarcomaovarian stromal cancer

Outcome Measures

Primary Outcomes (6)

  • Acquisition of epidemiological information and biological material

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

  • Risk associated with predisposing mutations

  • Effect of nongenetic risk factors in mutation carriers

  • Pathological and clinical characteristics of ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers

  • Exploration of mutations at other loci that may predispose to ovarian cancer

Interventions

polymorphism analysisGENETIC
laboratory biomarker analysisOTHER
questionnaire administrationOTHER

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Cambridge Cancer Research UK

Cambridge, England, CB1 8RN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Paul Pharoah, MD

    Cancer Research UK

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

February 1, 2008

Last Updated

August 26, 2013

Record last verified: 2008-09

Locations

GB(1)