CClinicalTrials.gg
Status unknownNCT00536718Updated Aug 12, 2013

Genetics of Women With Lobular Carcinoma in Situ of the Breast

An observational study in Breast Cancer, sponsored by National Cancer Research Network. Status unknown at 9 sites in United Kingdom. Open to female participants aged Up to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-12.

Sponsored by National Cancer Research Network · Observational

The sponsor has not verified this record recently (last verified Sep 2007), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Enrollment
3,000
Ages
Up to 60 Years
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

Keywords

  • invasive lobular breast carcinoma with predominant in situ component
  • invasive lobular breast carcinoma
  • lobular breast carcinoma in situ
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

This is the only study on the registry with National Cancer Research Network as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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
05

Study design

Enrollment
3,000 participants (estimated)
Patient registry
No

Interventions

  • Geneticgene expression analysis
  • Geneticmolecular diagnostic method
  • Geneticpolymorphism analysis
  • Geneticprotein expression analysis
  • Othermedical chart review
  • Otherquestionnaire administration
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What researchers measure

Primary outcomes

  1. Inherited variation predisposing development of lobular carcinoma in situ (LCIS) of the breast in women

  2. Frequency and effect of variants on tumor risk

  3. Clinical setting variant test value in identifying, counseling and screening those women at higher risk

Secondary outcomes

  1. LCIS genetic changes which may progress to invasive cancer

07

Study locations

9 of 9 sites recruiting
  • Basildon University Hospital
    Basildon, England SS16 5NL, United Kingdom
    • Contact Person · Contact · 44-1268-533-911
    Recruiting
  • Derbyshire Royal Infirmary
    Derby, England DE1 2QY, United Kingdom
    • Contact Person · Contact · 44-1332-347-141
    Recruiting
  • Leeds General Infirmary
    Leeds, England LS1 3EX, United Kingdom
    • Contact Person · Contact · 44-113-243-2799
    Recruiting
  • Guy's Hospital
    London, England SE1 9RT, United Kingdom
    • Contact Person · Contact · 44-20-7188-7188
    Recruiting
  • King's College Hospital
    London, England SE5 9RS, United Kingdom
    Recruiting
  • London Research Institute
    London, England WC2A 3PX, United Kingdom
    • Elinor Sawyer, MD · Contact · 44-20-7269-2884
    Recruiting
  • Southend University Hospital NHS Foundation Trust
    Westcliff-On-Sea, England SS0 0RY, United Kingdom
    • Contact Person · Contact · 44-1702-435-555
    Recruiting
  • Bronglais District General Hospital
    Aberystwyth, Wales SY23 1ER, United Kingdom
    • Contact Person · Contact · 44-1970-623-131
    Recruiting
  • Saint Bartholomew's Hospital
    London, United Kingdom
    • Contact Person · Contact · 44-20-7377-7000
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00536718
Lead sponsor
National Cancer Research Network
First posted
Sep 28, 2007
Start date
Jun 2007
Last update
Aug 12, 2013

Study contacts

Elinor Sawyer, MD
study chair · London Research Institute
Rebecca Roylance, MD
Barts and the London School of Medicine and Dentistry
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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