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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
DNA analysis
polymorphism analysis
protein analysis
laboratory biomarker analysis
questionnaire administration
survey administration
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring ductal breast carcinoma in situ

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • North Devon District HospitalRecruiting
  • Basildon University HospitalRecruiting
  • Cumberland InfirmaryRecruiting
  • Colchester General HospitalRecruiting
  • Dartford & Gravesham NHS Trust, Joyce Green HospitalRecruiting
  • Dorset County HospitalRecruiting
  • Northwick Park HospitalRecruiting
  • West Middlesex University HospitalRecruiting
  • Barts and the London School of MedicineRecruiting
  • Helen Rollason Cancer Care Centre at North Middlesex HospitalRecruiting
  • Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' HospitalsRecruiting
  • King's College HospitalRecruiting
  • Charing Cross HospitalRecruiting
  • Mount Vernon Cancer Centre at Mount Vernon HospitalRecruiting
  • Princess Royal University HospitalRecruiting
  • Southend University Hospital NHS Foundation TrustRecruiting
  • Dumfries & Galloway Royal InfirmaryRecruiting
  • Bronglais District General HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Analysis of acquired genetic changes within DCIS

Full Information

First Posted
July 7, 2009
Last Updated
August 9, 2013
Sponsor
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT00935233
Brief Title
Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers
Official Title
ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE
Study Type
Observational

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Queen Mary University of London

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
ductal breast carcinoma in situ

7. Study Design

Enrollment
6000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
DNA analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Genetic
Intervention Name(s)
protein analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Other
Intervention Name(s)
survey administration
Primary Outcome Measure Information:
Title
Collection of blood and/or tumor tissue
Title
Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS)
Title
Effect of these variants on tumor risk
Title
Benefit of testing for these variants
Secondary Outcome Measure Information:
Title
Analysis of acquired genetic changes within DCIS

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Roylance, MD
Organizational Affiliation
Barts and the London School of Medicine and Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elinor Sawyer, MD
Organizational Affiliation
Cancer Research UK
Facility Information:
Facility Name
North Devon District Hospital
City
Barnstaple
State/Province
England
ZIP/Postal Code
EX31 4JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1271-322-577
Facility Name
Basildon University Hospital
City
Basildon
State/Province
England
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1702-435-555
Facility Name
Cumberland Infirmary
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Williams, MD
Phone
44-122-321-7020
Email
michael.williams@addenbrookes.nhs.uk
Facility Name
Colchester General Hospital
City
Colchester
State/Province
England
ZIP/Postal Code
CO4 5HG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1206-744-893
Facility Name
Dartford & Gravesham NHS Trust, Joyce Green Hospital
City
Dartford Kent
State/Province
England
ZIP/Postal Code
DA1 5PL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1322-227-242
Facility Name
Dorset County Hospital
City
Dorchester
State/Province
England
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1305-251-150
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
England
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-8864-3232
Facility Name
West Middlesex University Hospital
City
Isleworth
State/Province
England
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-8321-6781
Facility Name
Barts and the London School of Medicine
City
London
State/Province
England
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Roylance, MD
Phone
44-20-7014-0460
Facility Name
Helen Rollason Cancer Care Centre at North Middlesex Hospital
City
London
State/Province
England
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-7830-2184
Facility Name
Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elinor Sawyer, MD
Phone
44-171-737-3642
Facility Name
King's College Hospital
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-3299-9000
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles P. Lowdell, MD, BSc, MBBS, FRCP, FRCR
Phone
44-20-8846-1742
Email
charles.lowdell@imperial.nhs.uk
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1923-844-805
Facility Name
Princess Royal University Hospital
City
Orpington, Kent
State/Province
England
ZIP/Postal Code
BR6 8ND
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elinor Sawyer, MD
Phone
44-20-7188-3751
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Robinson, MD
Phone
44-1702-221-226
Facility Name
Dumfries & Galloway Royal Infirmary
City
Dumfries
State/Province
Scotland
ZIP/Postal Code
DG1 4AP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1387-246-246
Facility Name
Bronglais District General Hospital
City
Aberystwyth
State/Province
Wales
ZIP/Postal Code
SY23 1ER
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1970-635-390

12. IPD Sharing Statement

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

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