Genetics of Women With Lobular Carcinoma in Situ of the Breast
- Conditions
- Breast Cancer
- Registration Number
- NCT00536718
- Lead Sponsor
- National Cancer Research Network
- Brief Summary
RATIONALE: Gathering information about genetic changes in patients with lobular carcinoma in situ of the breast may help doctors learn more about the disease and find better methods of treatment.
PURPOSE: This clinical trial is studying the genetics of women with lobular carcinoma in situ of the breast.
- Detailed Description
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 3000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Inherited variation predisposing development of lobular carcinoma in situ (LCIS) of the breast in women Clinical setting variant test value in identifying, counseling and screening those women at higher risk Frequency and effect of variants on tumor risk
- Secondary Outcome Measures
Name Time Method LCIS genetic changes which may progress to invasive cancer
Trial Locations
- Locations (9)
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
Basildon University Hospital🇬🇧Basildon, England, United Kingdom