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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen Mary University of London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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