Genetics of Women With Lobular Carcinoma in Situ of the Breast

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00536718
• Other study ID #: NCRN-CRUK-GLACIER
• Secondary ID: CDR0000566209EU-
• Status: Recruiting
• Phase: N/A
• First received: September 27, 2007
• Last updated: August 9, 2013
• Start date: June 2007

Study information

• Verified date: September 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 60 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ
• Carcinoma, Lobular

Intervention

Genetic:
• gene expression analysis

• molecular diagnostic method

• polymorphism analysis

• protein expression analysis

Other:
• medical chart review

• questionnaire administration

Locations

Country	Name	City	State
United Kingdom	Bronglais District General Hospital	Aberystwyth	Wales
United Kingdom	Basildon University Hospital	Basildon	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Leeds General Infirmary	Leeds	England
United Kingdom	Guy's Hospital	London	England
United Kingdom	King's College Hospital	London	England
United Kingdom	London Research Institute	London	England
United Kingdom	Saint Bartholomew's Hospital	London
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Research Network

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inherited variation predisposing development of lobular carcinoma in situ (LCIS) of the breast in women
Primary	Frequency and effect of variants on tumor risk
Primary	Clinical setting variant test value in identifying, counseling and screening those women at higher risk
Secondary	LCIS genetic changes which may progress to invasive cancer