Genetics of Women With Lobular Carcinoma in Situ of the Breast

Overview

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.

Full Title of Study: “GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope”

Study Type

  • Study Type: Observational

Detailed Description

OBJECTIVES: Primary – 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. Secondary – 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.

Interventions

  • Genetic: gene expression analysis
  • Genetic: molecular diagnostic method
  • Genetic: polymorphism analysis
  • Genetic: protein expression analysis
  • Other: medical chart review
  • Other: questionnaire administration

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • LCIS genetic changes which may progress to invasive cancer

Participating in This Clinical Trial

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
  • Gender Eligibility: Female

    Minimum Age: N/A

    Maximum Age: 60 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • National Cancer Research Network
    • Overall Official(s)
      • Elinor Sawyer, MD, Study Chair, London Research Institute
      • Rebecca Roylance, MD, , Barts and the London School of Medicine and Dentistry

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