Genetics of Women With Lobular Carcinoma in Situ of the Breast

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00536718
First received: September 27, 2007
Last updated: August 9, 2013
Last verified: September 2007
  Purpose

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.


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

Study Type: Observational
Official Title: GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Secondary Outcome Measures:
  • LCIS genetic changes which may progress to invasive cancer

Estimated Enrollment: 3000
Study Start Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536718

Locations
United Kingdom
Basildon University Hospital Recruiting
Basildon, England, United Kingdom, SS16 5NL
Contact: Contact Person    44-1268-533-911      
Derbyshire Royal Infirmary Recruiting
Derby, England, United Kingdom, DE1 2QY
Contact: Contact Person    44-1332-347-141      
Leeds General Infirmary Recruiting
Leeds, England, United Kingdom, LS1 3EX
Contact: Contact Person    44-113-243-2799      
Guy's Hospital Recruiting
London, England, United Kingdom, SE1 9RT
Contact: Contact Person    44-20-7188-7188      
King's College Hospital Recruiting
London, England, United Kingdom, SE5 9RS
Contact: Contact Person    44-20-3299-9000    info@kingsch.nhs.uk   
London Research Institute Recruiting
London, England, United Kingdom, WC2A 3PX
Contact: Elinor Sawyer, MD    44-20-7269-2884      
Southend University Hospital NHS Foundation Trust Recruiting
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Contact: Contact Person    44-1702-435-555      
Bronglais District General Hospital Recruiting
Aberystwyth, Wales, United Kingdom, SY23 1ER
Contact: Contact Person    44-1970-623-131      
Saint Bartholomew's Hospital Recruiting
London, United Kingdom
Contact: Contact Person    44-20-7377-7000      
Sponsors and Collaborators
National Cancer Research Network
Investigators
Study Chair: Elinor Sawyer, MD London Research Institute
Investigator: Rebecca Roylance, MD Barts and the London School of Medicine and Dentistry
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00536718     History of Changes
Other Study ID Numbers: NCRN-CRUK-GLACIER, CDR0000566209, EU-20760, MREC 06/Q1702/64, CRUK-GLACIER
Study First Received: September 27, 2007
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
invasive lobular breast carcinoma with predominant in situ component
invasive lobular breast carcinoma
lobular breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Lobular
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on July 24, 2014