Genetics of Women With Lobular Carcinoma in Situ of the Breast
Recruitment status was: Recruiting
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.
Genetic: gene expression analysis
Genetic: molecular diagnostic method
Genetic: polymorphism analysis
Genetic: protein expression analysis
Other: medical chart review
Other: questionnaire administration
|Official Title:||GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope|
- Inherited variation predisposing development of lobular carcinoma in situ (LCIS) of the breast in women
- Frequency and effect of variants on tumor risk
- Clinical setting variant test value in identifying, counseling and screening those women at higher risk
- LCIS genetic changes which may progress to invasive cancer
|Study Start Date:||June 2007|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536718
|Basildon University Hospital|
|Basildon, England, United Kingdom, SS16 5NL|
|Derbyshire Royal Infirmary|
|Derby, England, United Kingdom, DE1 2QY|
|Leeds General Infirmary|
|Leeds, England, United Kingdom, LS1 3EX|
|London, England, United Kingdom, SE1 9RT|
|King's College Hospital|
|London, England, United Kingdom, SE5 9RS|
|London Research Institute|
|London, England, United Kingdom, WC2A 3PX|
|Southend University Hospital NHS Foundation Trust|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Bronglais District General Hospital|
|Aberystwyth, Wales, United Kingdom, SY23 1ER|
|Saint Bartholomew's Hospital|
|London, United Kingdom|
|Study Chair:||Elinor Sawyer, MD||London Research Institute|
|OverallOfficial:||Rebecca Roylance, MD||Barts and the London School of Medicine and Dentistry|