Breast CancerNCT00935233
Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers
An observational study of Breast Cancer, run by Queen Mary University of London at 18 sites in United Kingdom.
Trial summary
RATIONALE: Studying genes in samples of blood and/or tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at blood and/or tumor tissue samples from patients with ductal carcinoma in situ and blood samples from healthy volunteers. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DNA analysis, polymorphism analysis and protein analysis
- How many people
- 6,000 participants
- Where
- 18 sitesUnited Kingdom
- Study dates
- Jul 2008to Jul 2010
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Prior or current diagnosis of pure ductal carcinoma in situ (DCIS)
- Age ≤ 60 years at the time of diagnosis
- DCIS with contralateral synchronous or asynchronous invasive breast cancer is permitted
- DCIS associated with microinvasion (foci < 1 mm) is permitted
- Healthy age- and ethnicity-matched controls
- No history of DCIS
- No relative (up to second degree) diagnosed with DCIS
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United Kingdom18 sites, 18 recruiting
- Recruiting
Bronglais District General Hospital
Aberystwyth, Wales, SY23 1ER
Contact Person, 44-1970-635-390
- Recruiting
North Devon District Hospital
Barnstaple, England, EX31 4JB
Contact Person, 44-1271-322-577
- Recruiting
Basildon University Hospital
Basildon, England, SS16 5NL
Contact Person, 44-1702-435-555
- Recruiting
Cumberland Infirmary
Cambridge, England, CB2 2QQ
Michael Williams, MD, 44-122-321-7020, michael.williams@addenbrookes.nhs.uk
- Recruiting
Colchester General Hospital
Colchester, England, CO4 5HG
Contact Person, 44-1206-744-893
- Recruiting
Dartford & Gravesham NHS Trust, Joyce Green Hospital
Dartford Kent, England, DA1 5PL
Contact Person, 44-1322-227-242
- Recruiting
Dorset County Hospital
Dorchester, England, DT1 2JY
Contact Person, 44-1305-251-150
- Recruiting
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland, DG1 4AP
Contact Person, 44-1387-246-246
- Recruiting
Northwick Park Hospital
Harrow, England, HA1 3UJ
Contact Person, 44-20-8864-3232
- Recruiting
West Middlesex University Hospital
Isleworth, England, TW7 6AF
Contact Person, 44-20-8321-6781
- Recruiting
Barts and the London School of Medicine
London, England, EC1M 6BQ
Rebecca Roylance, MD, 44-20-7014-0460
- Recruiting
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, N18 1QX
Contact Person, 44-20-7830-2184
- Recruiting
Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
London, England, SE1 9RT
Elinor Sawyer, MD, 44-171-737-3642
- Recruiting
King's College Hospital
London, England, SE5 9RS
Contact Person, 44-20-3299-9000
- Recruiting
Charing Cross Hospital
London, England, SW10 9NH
Charles P. Lowdell, MD, BSc, MBBS, FRCP, FRCR, 44-20-8846-1742, charles.lowdell@imperial.nhs.uk
- Recruiting
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Contact Person, 44-1923-844-805
- Recruiting
Princess Royal University Hospital
Orpington, Kent, England, BR6 8ND
Elinor Sawyer, MD, 44-20-7188-3751
- Recruiting
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Anne Robinson, MD, 44-1702-221-226
About this study
Official title: ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE
RATIONALE: Studying genes in samples of blood and/or tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood and/or tumor tissue samples from patients with ductal carcinoma in situ and blood samples from healthy volunteers.
Read the detailed description
OBJECTIVES:
Primary
- To collect blood and/or tumor tissue of patients with ductal breast carcinoma in situ (DCIS) and their age- and ethnicity-matched controls to identify the inherited variation that predisposes women to develop DCIS.
- To determine the frequency of these variants.
- To determine the effect of these variants on tumor risk.
- To determine the benefit of testing for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened.
Secondary
- To analyze the acquired genetic changes within DCIS to identify which cases are more likely to develop invasive disease.
OUTLINE: This is a multicenter study.
All participants complete a questionnaire to collect their family history, a brief medical history, and epidemiological data.
Patients undergo collection of blood and/or tumor tissue samples; DNA is extracted for genotyping, comparison of allele and genotype frequencies (polymorphisms), genetic profiling, DNA analysis, and protein analysis. Histopathology reports are also collected. Healthy volunteers undergo collection of blood samples.
PROJECTED ACCRUAL: A minimum of 3,000 patients and 3,000 controls will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- DNA analysis, polymorphism analysis, protein analysis, laboratory biomarker analysis, questionnaire administration
- Keywords
- ductal breast carcinoma in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
polymorphism analysisGenetic
protein analysisGenetic
laboratory biomarker analysisOther
questionnaire administrationOther
survey administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of blood and/or tumor tissue
Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS)
Effect of these variants on tumor risk
Benefit of testing for these variants
Secondary outcomes (1)
Analysis of acquired genetic changes within DCIS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2010 (estimated)
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.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Investigators
- Rebecca Roylance, MD, Principal investigator, Barts and the London School of Medicine and DentistryElinor Sawyer, MD, Cancer Research UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935233
- Sponsor's protocol ID
- CRUK-ICICLE
- Other IDs
- CDR0000629681, EU-20895
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2009
- 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
- ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE
- ClinicalTrials.gov ID
- NCT00935233
- Acronym / sponsor ID
- CRUK-ICICLE
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (estimated)
- First posted
- 8 Jul 2009 (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: Studying genes in samples of blood and/or tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood and/or tumor tissue samples from patients with ductal carcinoma in situ and blood samples from healthy volunteers.
Detailed description
OBJECTIVES:
Primary
- To collect blood and/or tumor tissue of patients with ductal breast carcinoma in situ (DCIS) and their age- and ethnicity-matched controls to identify the inherited variation that predisposes women to develop DCIS.
- To determine the frequency of these variants.
- To determine the effect of these variants on tumor risk.
- To determine the benefit of testing for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened.
Secondary
- To analyze the acquired genetic changes within DCIS to identify which cases are more likely to develop invasive disease.
OUTLINE: This is a multicenter study.
All participants complete a questionnaire to collect their family history, a brief medical history, and epidemiological data.
Patients undergo collection of blood and/or tumor tissue samples; DNA is extracted for genotyping, comparison of allele and genotype frequencies (polymorphisms), genetic profiling, DNA analysis, and protein analysis. Histopathology reports are also collected. Healthy volunteers undergo collection of blood samples.
PROJECTED ACCRUAL: A minimum of 3,000 patients and 3,000 controls will be accrued for this study.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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 |
|---|---|---|
| DNA analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| protein analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
| survey administration | Other | – |
Primary outcome
Collection of blood and/or tumor tissue
Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS)
Effect of these variants on tumor risk
Benefit of testing for these variants
1 secondary outcome
Analysis of acquired genetic changes within DCIS
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.
Rebecca Roylance, MD principal investigator
Barts and the London School of Medicine and Dentistry
Elinor Sawyer, MD
Cancer Research UK
18 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 Queen Mary University of London at 18 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
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 18 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?
Collection of blood and/or tumor tissue. The study lists 4 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.