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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000566209 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20760 | |||
| MREC 06/Q1702/64 | |||
| CRUK-GLACIER |
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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gene expression analysis | Genetic | |||
| molecular diagnostic method | Genetic | |||
| polymorphism analysis | Genetic | |||
| protein expression analysis | Genetic | |||
| medical chart review | Other | |||
| questionnaire administration | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| LCIS genetic changes which may progress to invasive cancer |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Elinor Sawyer, MD | London Research Institute | Study Chair |
| Rebecca Roylance, MD | Barts and the London School of Medicine and Dentistry |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basildon University Hospital | Recruiting | Basildon | England | SS16 5NL | United Kingdom |
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| Derbyshire Royal Infirmary | Recruiting | Derby | England | DE1 2QY | United Kingdom |
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| Leeds General Infirmary | Recruiting | Leeds | England | LS1 3EX | United Kingdom |
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| Guy's Hospital | Recruiting | London | England | SE1 9RT | United Kingdom |
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| King's College Hospital | Recruiting | London | England | SE5 9RS | United Kingdom |
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| London Research Institute | Recruiting | London | England | WC2A 3PX | United Kingdom |
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| Southend University Hospital NHS Foundation Trust | Recruiting | Westcliff-on-Sea | England | SS0 0RY | United Kingdom |
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| Bronglais District General Hospital | Recruiting | Aberystwyth | Wales | SY23 1ER | United Kingdom |
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| Saint Bartholomew's Hospital | Recruiting | London | United Kingdom |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018275 | Carcinoma, Lobular |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D002278 | Carcinoma in Situ |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D025202 | Molecular Diagnostic Techniques |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D016172 | DNA Fingerprinting |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
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