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Status unknownNCT00935233Updated Aug 12, 2013

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

An observational study in Breast Cancer, sponsored by Queen Mary University of London. Status unknown at 18 sites in United Kingdom. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-12.

Sponsored by Queen Mary University of London · Observational

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Enrollment
6,000
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer

Keywords

  • ductal breast carcinoma in situ
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In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Queen Mary University of London is the lead sponsor of 253 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

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
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Study design

Enrollment
6,000 participants (estimated)
Patient registry
No

Interventions

  • GeneticDNA analysis
  • Geneticpolymorphism analysis
  • Geneticprotein analysis
  • Otherlaboratory biomarker analysis
  • Otherquestionnaire administration
  • Othersurvey administration
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What researchers measure

Primary outcomes

  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 outcomes

  1. Analysis of acquired genetic changes within DCIS

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Study locations

18 of 18 sites recruiting
  • North Devon District Hospital
    Barnstaple, England EX31 4JB, United Kingdom
    • Contact Person · Contact · 44-1271-322-577
    Recruiting
  • Basildon University Hospital
    Basildon, England SS16 5NL, United Kingdom
    • Contact Person · Contact · 44-1702-435-555
    Recruiting
  • Cumberland Infirmary
    Cambridge, England CB2 2QQ, United Kingdom
    Recruiting
  • Colchester General Hospital
    Colchester, England CO4 5HG, United Kingdom
    • Contact Person · Contact · 44-1206-744-893
    Recruiting
  • Dartford & Gravesham NHS Trust, Joyce Green Hospital
    Dartford Kent, England DA1 5PL, United Kingdom
    • Contact Person · Contact · 44-1322-227-242
    Recruiting
  • Dorset County Hospital
    Dorchester, England DT1 2JY, United Kingdom
    • Contact Person · Contact · 44-1305-251-150
    Recruiting
  • Northwick Park Hospital
    Harrow, England HA1 3UJ, United Kingdom
    • Contact Person · Contact · 44-20-8864-3232
    Recruiting
  • West Middlesex University Hospital
    Isleworth, England TW7 6AF, United Kingdom
    • Contact Person · Contact · 44-20-8321-6781
    Recruiting
  • Barts and the London School of Medicine
    London, England EC1M 6BQ, United Kingdom
    • Rebecca Roylance, MD · Contact · 44-20-7014-0460
    Recruiting
  • Helen Rollason Cancer Care Centre at North Middlesex Hospital
    London, England N18 1QX, United Kingdom
    • Contact Person · Contact · 44-20-7830-2184
    Recruiting
  • Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
    London, England SE1 9RT, United Kingdom
    • Elinor Sawyer, MD · Contact · 44-171-737-3642
    Recruiting
  • King's College Hospital
    London, England SE5 9RS, United Kingdom
    • Contact Person · Contact · 44-20-3299-9000
    Recruiting
  • Charing Cross Hospital
    London, England SW10 9NH, United Kingdom
    Recruiting
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
    Northwood, England HA6 2RN, United Kingdom
    • Contact Person · Contact · 44-1923-844-805
    Recruiting
  • Princess Royal University Hospital
    Orpington, Kent, England BR6 8ND, United Kingdom
    • Elinor Sawyer, MD · Contact · 44-20-7188-3751
    Recruiting
  • Southend University Hospital NHS Foundation Trust
    Westcliff-on-Sea, England SS0 0RY, United Kingdom
    • Anne Robinson, MD · Contact · 44-1702-221-226
    Recruiting
  • Dumfries & Galloway Royal Infirmary
    Dumfries, Scotland DG1 4AP, United Kingdom
    • Contact Person · Contact · 44-1387-246-246
    Recruiting
  • Bronglais District General Hospital
    Aberystwyth, Wales SY23 1ER, United Kingdom
    • Contact Person · Contact · 44-1970-635-390
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00935233
First posted
Jul 8, 2009
Start date
Jul 2008
Primary completion
Jul 2010 (estimated)
Last update
Aug 12, 2013

Study contacts

Rebecca Roylance, MD
principal investigator · Barts and the London School of Medicine and Dentistry
Elinor Sawyer, MD
Cancer Research UK
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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