Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00935233
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : July 8, 2009
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment
Breast Cancer Genetic: DNA analysis Genetic: polymorphism analysis Genetic: protein analysis Other: laboratory biomarker analysis Other: questionnaire administration Other: survey administration

Detailed Description:



  • 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.

Study Type : Observational
Estimated Enrollment : 6000 participants
Official Title: ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE
Study Start Date : July 2008
Estimated Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Collection of blood and/or tumor tissue
  2. Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS)
  3. Effect of these variants on tumor risk
  4. Benefit of testing for these variants

Secondary Outcome Measures :
  1. Analysis of acquired genetic changes within DCIS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes


  • 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


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00935233

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   
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      
Barts and the London School of Medicine Recruiting
London, England, United Kingdom, EC1M 6BQ
Contact: Rebecca Roylance, MD    44-20-7014-0460      
Helen Rollason Cancer Care Centre at North Middlesex Hospital Recruiting
London, England, United Kingdom, N18 1QX
Contact: Contact Person    44-20-7830-2184      
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      
King's College Hospital Recruiting
London, England, United Kingdom, SE5 9RS
Contact: Contact Person    44-20-3299-9000      
Charing Cross Hospital Recruiting
London, England, United Kingdom, SW10 9NH
Contact: Charles P. Lowdell, MD, BSc, MBBS, FRCP, FRCR    44-20-8846-1742   
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
Principal Investigator: Rebecca Roylance, MD Barts and the London School of Medicine and Dentistry
OverallOfficial: Elinor Sawyer, MD Cancer Research UK Identifier: NCT00935233     History of Changes
Other Study ID Numbers: CRUK-ICICLE
CDR0000629681 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type