Clinical trial NCT00536718: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: invasive lobular breast carcinoma with predominant in situ component
invasive lobular breast carcinoma
lobular breast carcinoma in situ
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-09-28
Enrollment: 3000
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes

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.

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

Primary outcomes:
measure: Inherited variation predisposing development of lobular carcinoma in situ (LCIS) of the breast in women
measure: Frequency and effect of variants on tumor risk
measure: Clinical setting variant test value in identifying, counseling and screening those women at higher risk
Secondary outcomes:
measure: LCIS genetic changes which may progress to invasive cancer
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: England
city: London
country: United Kingdom
facility: Guy's Hospital
state: England
city: London
country: United Kingdom
facility: King's College Hospital
state: England
city: London
country: United Kingdom
facility: London Research Institute
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
state: England
city: Aberystwyth
country: United Kingdom
facility: Bronglais District General Hospital
state: Wales
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
Study officials:
affiliation: London Research Institute
name: Elinor Sawyer, MD
role: STUDY_CHAIR
affiliation: Barts and the London School of Medicine and Dentistry
name: Rebecca Roylance, MD
References: