Genetics of Women With Lobular Carcinoma in Situ of the Breast
NCT ID: NCT00536718
Last Updated: 2013-08-12
Study Results
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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UNKNOWN
3000 participants
OBSERVATIONAL
2007-06-30
Brief Summary
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PURPOSE: This clinical trial is studying the genetics of women with lobular carcinoma in situ of the breast.
Detailed Description
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Primary
* Identify inherited variation that predisposes women to develop lobular carcinoma in situ (LCIS) of the breast.
* Identify the frequency of these variants and determine the effect they have on tumor risk.
* Determine how worthwhile it would be to test for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened.
Secondary
* Analysis of genetic changes within LCIS with the aim of identifying cases of LCIS which may progress to invasive cancer.
OUTLINE: Patients and control participants undergo blood collection. DNA is extracted from blood samples and used to genotype at selected polymorphisms, compare allele frequencies (used to associate alleles with disease) using a genome-wide single nucleotide polymorphism (SNP) screen. Archival tumor samples (if available) from patients are used for DNA-, RNA-, or protein-based analyses.
All participants complete a questionnaire about family history, a brief medical history, and provide epidemiological data to a genetic counselor. Participants identified to be at risk for known hereditary predisposition to cancer will be referred to a clinical genetics service. Individual results of this study are not disclosed to participants.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
PROJECTED ACCRUAL: A total of 2,000 participants (1,000 patients and 1,000 matched controls) will be accrued for this study.
Conditions
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Keywords
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Interventions
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gene expression analysis
molecular diagnostic method
polymorphism analysis
protein expression analysis
medical chart review
questionnaire administration
Eligibility Criteria
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Inclusion Criteria
* Meets 1 of the following criteria:
* Current or prior diagnosis of lobular carcinoma in situ (LCIS) of the breast, including any of the following cases:
* Pure LCIS
* LCIS with subsequent development of invasive breast cancer of any morphological subtype
* LCIS presenting as an incidental finding together with invasive breast cancer of any morphological subtype
* Control participant matched for age and ethnicity to each LCIS patient
* Not affected by LCIS
* No history of ductal carcinoma in situ of the breast
* No breast cancer
* No relative (up to 2nd degree) who has been affected by breast cancer
* Male or female
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
60 Years
FEMALE
Yes
Sponsors
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National Cancer Research Network
NETWORK
Principal Investigators
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Elinor Sawyer, MD
Role: STUDY_CHAIR
London Research Institute
Rebecca Roylance, MD
Role:
Barts and the London School of Medicine and Dentistry
Locations
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Basildon University Hospital
Basildon, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Leeds General Infirmary
Leeds, England, United Kingdom
Guy's Hospital
London, England, United Kingdom
King's College Hospital
London, England, United Kingdom
London Research Institute
London, England, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, United Kingdom
Bronglais District General Hospital
Aberystwyth, Wales, United Kingdom
Saint Bartholomew's Hospital
London, , United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Elinor Sawyer, MD
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Other Identifiers
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CDR0000566209
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20760
Identifier Type: -
Identifier Source: secondary_id
MREC 06/Q1702/64
Identifier Type: -
Identifier Source: secondary_id
CRUK-GLACIER
Identifier Type: -
Identifier Source: secondary_id
NCRN-CRUK-GLACIER
Identifier Type: -
Identifier Source: org_study_id