Genetics of Women With Lobular Carcinoma in Situ of the Breast

NCT00536718 | Unknown

• 5 other identifiers: NCRN-CRUK-GLACIERCDR0000566209EU-20760MREC 06/Q1702/64CRUK-GLACIER
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Breast Cancer

Keywords

invasive lobular breast carcinoma with predominant in situ component; invasive lobular breast carcinoma; lobular breast carcinoma in situ

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• LCIS genetic changes which may progress to invasive cancer

Interventions

gene expression analysis GENETIC

molecular diagnostic method GENETIC

polymorphism analysis GENETIC

protein expression analysis GENETIC

medical chart review OTHER

questionnaire administration OTHER

Eligibility Criteria

• Age: Up to 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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: * Pure LCIS * LCIS with subsequent development of invasive breast cancer of any morphological subtype * LCIS presenting as an incidental finding together with invasive breast cancer of any morphological subtype * Control participant matched for age and ethnicity to each LCIS patient * Not affected by LCIS * No history of ductal carcinoma in situ of the breast * No breast cancer * No relative (up to 2nd degree) who has been affected by breast cancer * Male or female PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Research Network: lead

Study Sites (9)

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

RECRUITING

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

RECRUITING

Leeds General Infirmary

Leeds, England, LS1 3EX, United Kingdom

RECRUITING

Guy's Hospital

London, England, SE1 9RT, United Kingdom

RECRUITING

King's College Hospital

London, England, SE5 9RS, United Kingdom

RECRUITING

London Research Institute

London, England, WC2A 3PX, United Kingdom

RECRUITING

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

RECRUITING

Bronglais District General Hospital

Aberystwyth, Wales, SY23 1ER, United Kingdom

RECRUITING

Saint Bartholomew's Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Lobular; Breast Carcinoma In Situ

Interventions

Gene Expression Profiling; Molecular Diagnostic Techniques; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma in Situ

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Elinor Sawyer, MD

  London Research Institute

  STUDY CHAIR

• Rebecca Roylance, MD

  Barts and the London School of Medicine and Dentistry

Study Design

• Study Type: observational
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: June 1, 2007
• Last Updated: August 12, 2013

Record last verified: 2007-09

Locations

GB (9)