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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00935233
First received: July 7, 2009
Last updated: August 9, 2013
Last verified: July 2009
  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)
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.

  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: CRUK-ICICLE, CDR0000629681, EU-20895
Study First Received: July 7, 2009
Last Updated: August 9, 2013
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 April 16, 2014