NCT00896818

Brief Summary

RATIONALE: Studying samples of blood, urine, and tumor tissue in the laboratory from patients with cancer and their female relatives and friends may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at genes and other risk factors for second primary breast cancer in women with breast cancer and in their female family members and friends.

Trial Health

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Trial Health Score

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

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

January 1, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

August 26, 2013

Status Verified

June 1, 2009

Enrollment Period

4 years

First QC Date

May 9, 2009

Last Update Submit

August 23, 2013

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (4)

  • Prevalence of polymorphisms in candidate genes in contralateral patients and controls

  • Prevalence of alleles in breast cancer patients from multiple-case families and those in blood-unrelated family controls

  • Linkage analysis to detect new susceptibility genes in larger multiple-case families combined with data on families previously collected by the Institute of Cancer Research

  • Relationships between candidate gene polymorphisms and hormone levels in relatives and controls

Secondary Outcomes (1)

  • Average hormone levels in contralateral patients' first-degree relatives and controls

Interventions

DNA analysisGENETIC
genetic linkage analysisGENETIC
loss of heterozygosity analysisGENETIC
polymorphism analysisGENETIC
laboratory biomarker analysisOTHER
medical chart reviewOTHER
questionnaire administrationOTHER

Eligibility Criteria

AgeUp to 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Women who have been diagnosed with contralateral or unilateral breast cancer * Family controls, including sisters and adult daughters of contralateral cases, female relatives by marriage * Unrelated controls (i.e., friends) * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Pre- or postmenopausal 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)

London School of Hygiene and Tropical Medicine

London, England, WC1E 7HT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Genetic LinkageAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic PhenomenaDNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Julian Peto, MD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

January 1, 2005

Primary Completion

January 1, 2009

Last Updated

August 26, 2013

Record last verified: 2009-06

Locations

GB(1)