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

August 9, 2013 updated by: Queen Mary University of London

ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Barnstaple, England, United Kingdom, EX31 4JB
        • Recruiting
        • North Devon District Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1271-322-577
      • Basildon, England, United Kingdom, SS16 5NL
        • Recruiting
        • Basildon University Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1702-435-555
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Recruiting
        • Cumberland Infirmary
      • Colchester, England, United Kingdom, CO4 5HG
        • Recruiting
        • Colchester General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1206-744-893
      • Dartford Kent, England, United Kingdom, DA1 5PL
        • Recruiting
        • Dartford & Gravesham NHS Trust, Joyce Green Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1322-227-242
      • Dorchester, England, United Kingdom, DT1 2JY
        • Recruiting
        • Dorset County Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1305-251-150
      • Harrow, England, United Kingdom, HA1 3UJ
        • Recruiting
        • Northwick Park Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-20-8864-3232
      • Isleworth, England, United Kingdom, TW7 6AF
        • Recruiting
        • West Middlesex University Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-20-8321-6781
      • London, England, United Kingdom, N18 1QX
        • Recruiting
        • Helen Rollason Cancer Care Centre at North Middlesex Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-20-7830-2184
      • London, England, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-20-3299-9000
      • London, England, United Kingdom, EC1M 6BQ
        • Recruiting
        • Barts and the London School of Medicine
        • Contact:
          • Rebecca Roylance, MD
          • Phone Number: 44-20-7014-0460
      • London, England, United Kingdom, SE1 9RT
        • Recruiting
        • Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
        • Contact:
          • Elinor Sawyer, MD
          • Phone Number: 44-171-737-3642
      • London, England, United Kingdom, SW10 9NH
        • Recruiting
        • Charing Cross Hospital
        • Contact:
      • Northwood, England, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1923-844-805
      • Orpington, Kent, England, United Kingdom, BR6 8ND
        • Recruiting
        • Princess Royal University Hospital
        • Contact:
          • Elinor Sawyer, MD
          • Phone Number: 44-20-7188-3751
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Recruiting
        • Southend University Hospital NHS Foundation Trust
        • Contact:
          • Anne Robinson, MD
          • Phone Number: 44-1702-221-226
    • Scotland
      • Dumfries, Scotland, United Kingdom, DG1 4AP
        • Recruiting
        • Dumfries & Galloway Royal Infirmary
        • Contact:
          • Contact Person
          • Phone Number: 44-1387-246-246
    • Wales
      • Aberystwyth, Wales, United Kingdom, SY23 1ER
        • Recruiting
        • Bronglais District General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1970-635-390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Analysis of acquired genetic changes within DCIS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Investigators

  • Principal Investigator: Rebecca Roylance, MD, Barts and The London School of Medicine and Dentistry
  • Elinor Sawyer, MD, Cancer Research UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRUK-ICICLE
  • CDR0000629681 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20895

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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