Genetics of Women With Lobular Carcinoma in Situ of the Breast
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|ClinicalTrials.gov Identifier: NCT00536718|
Recruitment Status : Unknown
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 28, 2007
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: gene expression analysis Genetic: molecular diagnostic method Genetic: polymorphism analysis Genetic: protein expression analysis Other: medical chart review Other: questionnaire administration|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope|
|Study Start Date :||June 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536718
|Basildon University Hospital||Recruiting|
|Basildon, England, United Kingdom, SS16 5NL|
|Contact: Contact Person 44-1268-533-911|
|Derbyshire Royal Infirmary||Recruiting|
|Derby, England, United Kingdom, DE1 2QY|
|Contact: Contact Person 44-1332-347-141|
|Leeds General Infirmary||Recruiting|
|Leeds, England, United Kingdom, LS1 3EX|
|Contact: Contact Person 44-113-243-2799|
|London, England, United Kingdom, SE1 9RT|
|Contact: Contact Person 44-20-7188-7188|
|King's College Hospital||Recruiting|
|London, England, United Kingdom, SE5 9RS|
|Contact: Contact Person 44-20-3299-9000 firstname.lastname@example.org|
|London Research Institute||Recruiting|
|London, England, United Kingdom, WC2A 3PX|
|Contact: Elinor Sawyer, MD 44-20-7269-2884|
|Southend University Hospital NHS Foundation Trust||Recruiting|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Contact: Contact Person 44-1702-435-555|
|Bronglais District General Hospital||Recruiting|
|Aberystwyth, Wales, United Kingdom, SY23 1ER|
|Contact: Contact Person 44-1970-623-131|
|Saint Bartholomew's Hospital||Recruiting|
|London, United Kingdom|
|Contact: Contact Person 44-20-7377-7000|
|Study Chair:||Elinor Sawyer, MD||London Research Institute|
|OverallOfficial:||Rebecca Roylance, MD||Barts and the London School of Medicine and Dentistry|