Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers
ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE
3 other identifiers
observational
6,000
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedAugust 12, 2013
July 1, 2009
2 years
July 7, 2009
August 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (18)
North Devon District Hospital
Barnstaple, England, EX31 4JB, United Kingdom
Basildon University Hospital
Basildon, England, SS16 5NL, United Kingdom
Cumberland Infirmary
Cambridge, England, CB2 2QQ, United Kingdom
Colchester General Hospital
Colchester, England, CO4 5HG, United Kingdom
Dartford & Gravesham NHS Trust, Joyce Green Hospital
Dartford Kent, England, DA1 5PL, United Kingdom
Dorset County Hospital
Dorchester, England, DT1 2JY, United Kingdom
Northwick Park Hospital
Harrow, England, HA1 3UJ, United Kingdom
West Middlesex University Hospital
Isleworth, England, TW7 6AF, United Kingdom
Barts and the London School of Medicine
London, England, EC1M 6BQ, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, N18 1QX, United Kingdom
Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
London, England, SE1 9RT, United Kingdom
King's College Hospital
London, England, SE5 9RS, United Kingdom
Charing Cross Hospital
London, England, SW10 9NH, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN, United Kingdom
Princess Royal University Hospital
Orpington, Kent, England, BR6 8ND, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY, United Kingdom
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland, DG1 4AP, United Kingdom
Bronglais District General Hospital
Aberystwyth, Wales, SY23 1ER, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Roylance, MD
Barts and the London School of Medicine and Dentistry
Elinor Sawyer, MD
Cancer Research UK
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 8, 2009
Study Start
July 1, 2008
Primary Completion
July 1, 2010
Last Updated
August 12, 2013
Record last verified: 2009-07