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Sponsored by: |
National Cancer Research Network |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00536718 |
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 | Intervention |
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Breast Cancer |
Genetic: gene expression analysis Genetic: molecular diagnostic method Genetic: polymorphism analysis Genetic: protein expression analysis Other: medical chart review Other: questionnaire administration |
Study Type: | Observational |
Official Title: | GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope |
Estimated Enrollment: | 2000 |
Study Start Date: | June 2007 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | up to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
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:
Control participant matched for age and ethnicity to each LCIS patient
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom | |
Saint Bartholomew's Hospital | Recruiting |
London, United Kingdom | |
Contact: Contact Person 44-20-7377-7000 | |
United Kingdom, England | |
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 | |
Guy's Hospital | Recruiting |
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 info@kingsch.nhs.uk | |
Leeds General Infirmary | Recruiting |
Leeds, England, United Kingdom, LS1 3EX | |
Contact: Contact Person 44-113-243-2799 | |
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 | |
United Kingdom, Wales | |
Bronglais District General Hospital | Recruiting |
Aberystwyth, Wales, United Kingdom, SY23 1ER | |
Contact: Contact Person 44-1970-623-131 |
Study Chair: | Elinor Sawyer, MD | London Research Institute |
Investigator: | Rebecca Roylance, MD | Barts and the London School of Medicine and Dentistry |
Study ID Numbers: | CDR0000566209, NCRN-CRUK-GLACIER, EU-20760, MREC 06/Q1702/64, CRUK-GLACIER |
Study First Received: | September 27, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00536718 History of Changes |
Health Authority: | Unspecified |
invasive lobular breast carcinoma with predominant in situ component invasive lobular breast carcinoma lobular breast carcinoma in situ |
Carcinoma, Lobular Skin Diseases Carcinoma in Situ Breast Neoplasms |
Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Carcinoma, Lobular Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases Carcinoma in Situ |
Breast Neoplasms Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |