Genetics of Women With Lobular Carcinoma in Situ of the Breast - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 27, 2007

Last Updated Date

February 6, 2009

Start Date ^†

June 2007

Current Primary Outcome 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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00536718 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

LCIS genetic changes which may progress to invasive cancer

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Genetics of Women With Lobular Carcinoma in Situ of the Breast

Official Title ^†

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

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.

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 Phase

Study Type ^†

Observational

Study Design ^†

Condition ^†

Breast Cancer

Intervention ^†

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

2000

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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

Female

Ages

up to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00536718

Responsible Party

Secondary IDs ^††

NCRN-CRUK-GLACIER, EU-20760, MREC 06/Q1702/64, CRUK-GLACIER

Study Sponsor ^†

National Cancer Research Network

Collaborators ^††

Investigators ^†

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.