Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers
Recruitment status was: Recruiting
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.
Genetic: DNA analysis
Genetic: polymorphism analysis
Genetic: protein analysis
Other: laboratory biomarker analysis
Other: questionnaire administration
Other: survey administration
|Official Title:||ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE|
- 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 ]
- Analysis of acquired genetic changes within DCIS [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935233
|North Devon District Hospital|
|Barnstaple, England, United Kingdom, EX31 4JB|
|Basildon University Hospital|
|Basildon, England, United Kingdom, SS16 5NL|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Colchester General Hospital|
|Colchester, England, United Kingdom, CO4 5HG|
|Dartford & Gravesham NHS Trust, Joyce Green Hospital|
|Dartford Kent, England, United Kingdom, DA1 5PL|
|Dorset County Hospital|
|Dorchester, England, United Kingdom, DT1 2JY|
|Northwick Park Hospital|
|Harrow, England, United Kingdom, HA1 3UJ|
|West Middlesex University Hospital|
|Isleworth, England, United Kingdom, TW7 6AF|
|Barts and the London School of Medicine|
|London, England, United Kingdom, EC1M 6BQ|
|Helen Rollason Cancer Care Centre at North Middlesex Hospital|
|London, England, United Kingdom, N18 1QX|
|Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals|
|London, England, United Kingdom, SE1 9RT|
|King's College Hospital|
|London, England, United Kingdom, SE5 9RS|
|Charing Cross Hospital|
|London, England, United Kingdom, SW10 9NH|
|Mount Vernon Cancer Centre at Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Princess Royal University Hospital|
|Orpington, Kent, England, United Kingdom, BR6 8ND|
|Southend University Hospital NHS Foundation Trust|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Dumfries & Galloway Royal Infirmary|
|Dumfries, Scotland, United Kingdom, DG1 4AP|
|Bronglais District General Hospital|
|Aberystwyth, Wales, United Kingdom, SY23 1ER|
|Principal Investigator:||Rebecca Roylance, MD||Barts and the London School of Medicine and Dentistry|
|OverallOfficial:||Elinor Sawyer, MD||Cancer Research UK|