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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Research Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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