Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Queen Mary University of London
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00935233
First received: July 7, 2009
Last updated: July 15, 2009
Last verified: July 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Genetic: DNA analysis Genetic: polymorphism analysis Genetic: protein analysis Other: laboratory biomarker analysis Other: questionnaire administration Other: survey administration |
| Study Type: | Observational |
| Official Title: | ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Collection of blood and/or tumor tissue [ Designated as safety issue: No ]
- Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS) [ Designated as safety issue: No ]
- Effect of these variants on tumor risk [ Designated as safety issue: No ]
- Benefit of testing for these variants [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Analysis of acquired genetic changes within DCIS [ Designated as safety issue: No ]
| Estimated Enrollment: | 6000 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935233
Locations
| United Kingdom | |
| North Devon District Hospital | Recruiting |
| Barnstaple, England, United Kingdom, EX31 4JB | |
| Contact: Contact Person 44-1271-322-577 | |
| Basildon University Hospital | Recruiting |
| Basildon, England, United Kingdom, SS16 5NL | |
| Contact: Contact Person 44-1702-435-555 | |
| Cumberland Infirmary | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Michael Williams, MD 44-122-321-7020 michael.williams@addenbrookes.nhs.uk | |
| Colchester General Hospital | Recruiting |
| Colchester, England, United Kingdom, CO4 5HG | |
| Contact: Contact Person 44-1206-744-893 | |
| Dartford & Gravesham NHS Trust, Joyce Green Hospital | Recruiting |
| Dartford Kent, England, United Kingdom, DA1 5PL | |
| Contact: Contact Person 44-1322-227-242 | |
| Dorset County Hospital | Recruiting |
| Dorchester, England, United Kingdom, DT1 2JY | |
| Contact: Contact Person 44-1305-251-150 | |
| Northwick Park Hospital | Recruiting |
| Harrow, England, United Kingdom, HA1 3UJ | |
| Contact: Contact Person 44-20-8864-3232 | |
| West Middlesex University Hospital | Recruiting |
| Isleworth, England, United Kingdom, TW7 6AF | |
| Contact: Contact Person 44-20-8321-6781 | |
| Charing Cross Hospital | Recruiting |
| London, England, United Kingdom, SW10 9NH | |
| Contact: Charles P. Lowdell, MD, BSc, MBBS, FRCP, FRCR 44-20-8846-1742 charles.lowdell@imperial.nhs.uk | |
| Barts and the London School of Medicine | Recruiting |
| London, England, United Kingdom, EC1M 6BQ | |
| Contact: Rebecca Roylance, MD 44-20-7014-0460 | |
| Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals | Recruiting |
| London, England, United Kingdom, SE1 9RT | |
| Contact: Elinor Sawyer, MD 44-171-737-3642 | |
| Helen Rollason Cancer Care Centre at North Middlesex Hospital | Recruiting |
| London, England, United Kingdom, N18 1QX | |
| Contact: Contact Person 44-20-7830-2184 | |
| King's College Hospital | Recruiting |
| London, England, United Kingdom, SE5 9RS | |
| Contact: Contact Person 44-20-3299-9000 | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
| Northwood, England, United Kingdom, HA6 2RN | |
| Contact: Contact Person 44-1923-844-805 | |
| Princess Royal University Hospital | Recruiting |
| Orpington, Kent, England, United Kingdom, BR6 8ND | |
| Contact: Elinor Sawyer, MD 44-20-7188-3751 | |
| Southend University Hospital NHS Foundation Trust | Recruiting |
| Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
| Contact: Anne Robinson, MD 44-1702-221-226 | |
| Dumfries & Galloway Royal Infirmary | Recruiting |
| Dumfries, Scotland, United Kingdom, DG1 4AP | |
| Contact: Contact Person 44-1387-246-246 | |
| Bronglais District General Hospital | Recruiting |
| Aberystwyth, Wales, United Kingdom, SY23 1ER | |
| Contact: Contact Person 44-1970-635-390 | |
Sponsors and Collaborators
Queen Mary University of London
Investigators
| Principal Investigator: | Rebecca Roylance, MD | Barts and the London School of Medicine and Dentistry |
| Investigator: | Elinor Sawyer, MD | Cancer Research UK |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00935233 History of Changes |
| Other Study ID Numbers: | CDR0000629681, CRUK-ICICLE, EU-20895 |
| Study First Received: | July 7, 2009 |
| Last Updated: | July 15, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
ductal breast carcinoma in situ |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating 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 May 21, 2013