Breast CancerNCT00536718
Genetics of Women With Lobular Carcinoma in Situ of the Breast
An observational study of Breast Cancer, run by National Cancer Research Network at 9 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- gene expression analysis, molecular diagnostic method and polymorphism analysis
- How many people
- 3,000 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Jun 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites, 9 recruiting
- Recruiting
Bronglais District General Hospital
Aberystwyth, Wales, SY23 1ER
Contact Person, 44-1970-623-131
- Recruiting
Basildon University Hospital
Basildon, England, SS16 5NL
Contact Person, 44-1268-533-911
- Recruiting
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Contact Person, 44-1332-347-141
- Recruiting
Leeds General Infirmary
Leeds, England, LS1 3EX
Contact Person, 44-113-243-2799
- Recruiting
Guy's Hospital
London, England, SE1 9RT
Contact Person, 44-20-7188-7188
- Recruiting
King's College Hospital
London, England, SE5 9RS
Contact Person, 44-20-3299-9000, info@kingsch.nhs.uk
- Recruiting
London Research Institute
London, England, WC2A 3PX
Elinor Sawyer, MD, 44-20-7269-2884
- Recruiting
Saint Bartholomew's Hospital
London
Contact Person, 44-20-7377-7000
- Recruiting
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Contact Person, 44-1702-435-555
About this study
Official title: GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope
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.
- Conditions
- Breast Cancer
- Being tested
- gene expression analysis, molecular diagnostic method, polymorphism analysis, protein expression analysis, medical chart review
- Keywords
- invasive lobular breast carcinoma with predominant in situ component, invasive lobular breast carcinoma, lobular breast carcinoma in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Lobular, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
molecular diagnostic methodGenetic
polymorphism analysisGenetic
protein expression analysisGenetic
medical chart reviewOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
LCIS genetic changes which may progress to invasive cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Research Network
- Sponsor type
- Research network
- Investigators
- Elinor Sawyer, MD, Study chair, London Research InstituteRebecca Roylance, MD, Barts and the London School of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536718
- Sponsor's protocol ID
- NCRN-CRUK-GLACIER
- Other IDs
- CDR0000566209, EU-20760, MREC 06/Q1702/64, CRUK-GLACIER
- Status last verified
- Sep 2007
- First submitted
- 27 Sep 2007
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope
- ClinicalTrials.gov ID
- NCT00536718
- Acronym / sponsor ID
- NCRN-CRUK-GLACIER
- Conditions
- Breast Cancer
- Keywords
- invasive lobular breast carcinoma with predominant in situ component, invasive lobular breast carcinoma, lobular breast carcinoma in situ
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Cancer Research NetworkResearch network
- Study start
- Jun 2007
- First posted
- 28 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysis | Genetic | – |
| molecular diagnostic method | Genetic | – |
| polymorphism analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| medical chart review | Other | – |
| questionnaire administration | Other | – |
Primary outcome
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
1 secondary outcome
LCIS genetic changes which may progress to invasive cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elinor Sawyer, MD study chair
London Research Institute
Rebecca Roylance, MD
Barts and the London School of Medicine and Dentistry
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Cancer Research Network at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inherited variation predisposing development of lobular carcinoma in situ (LCIS) of the breast in women. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.