Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers
- Conditions
- Breast Cancer
- Registration Number
- NCT00935233
- Lead Sponsor
- Queen Mary University of London
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 6000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Analysis of acquired genetic changes within DCIS
Trial Locations
- Locations (18)
North Devon District Hospital
🇬🇧Barnstaple, England, United Kingdom
Colchester General Hospital
🇬🇧Colchester, England, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
🇬🇧London, England, United Kingdom
Basildon University Hospital
🇬🇧Basildon, England, United Kingdom
Cumberland Infirmary
🇬🇧Cambridge, England, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, England, United Kingdom
Dartford & Gravesham NHS Trust, Joyce Green Hospital
🇬🇧Dartford Kent, England, United Kingdom
West Middlesex University Hospital
🇬🇧Isleworth, England, United Kingdom
Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
🇬🇧London, England, United Kingdom
Northwick Park Hospital
🇬🇧Harrow, England, United Kingdom
Barts and the London School of Medicine
🇬🇧London, England, United Kingdom
King's College Hospital
🇬🇧London, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Princess Royal University Hospital
🇬🇧Orpington, Kent, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Dumfries & Galloway Royal Infirmary
🇬🇧Dumfries, Scotland, United Kingdom
Bronglais District General Hospital
🇬🇧Aberystwyth, Wales, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom