Breast Cancer Clinical Trial
Official title:
GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope
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.
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.
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