Genetics of Women With Lobular Carcinoma in Situ of the Breast

August 9, 2013 updated by: National Cancer Research Network

GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Saint Bartholomew's Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-20-7377-7000
    • England
      • Basildon, England, United Kingdom, SS16 5NL
        • Recruiting
        • Basildon University Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1268-533-911
      • Derby, England, United Kingdom, DE1 2QY
        • Recruiting
        • Derbyshire Royal Infirmary
        • Contact:
          • Contact Person
          • Phone Number: 44-1332-347-141
      • Leeds, England, United Kingdom, LS1 3EX
        • Recruiting
        • Leeds General Infirmary
        • Contact:
          • Contact Person
          • Phone Number: 44-113-243-2799
      • London, England, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Contact:
      • London, England, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-20-7188-7188
      • London, England, United Kingdom, WC2A 3PX
        • Recruiting
        • London Research Institute
        • Contact:
          • Elinor Sawyer, MD
          • Phone Number: 44-20-7269-2884
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Recruiting
        • Southend University Hospital NHS Foundation Trust
        • Contact:
          • Contact Person
          • Phone Number: 44-1702-435-555
    • Wales
      • Aberystwyth, Wales, United Kingdom, SY23 1ER
        • Recruiting
        • Bronglais District General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1970-623-131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
LCIS genetic changes which may progress to invasive cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Research Network

Investigators

  • Study Chair: Elinor Sawyer, MD, London Research Institute
  • Rebecca Roylance, MD, Barts and The London School of Medicine and Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimate)

September 28, 2007

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRN-CRUK-GLACIER
  • CDR0000566209 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20760
  • MREC 06/Q1702/64
  • CRUK-GLACIER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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