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

July 7, 2009
August 9, 2013
July 2008
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00935233 on ClinicalTrials.gov Archive Site
Analysis of acquired genetic changes within DCIS [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers
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.

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.

Observational
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Breast Cancer
  • Genetic: DNA analysis
  • Genetic: polymorphism analysis
  • Genetic: protein analysis
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
  • Other: survey administration
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6000
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
United Kingdom
 
NCT00935233
CRUK-ICICLE, CDR0000629681, EU-20895
Not Provided
Not Provided
Queen Mary University of London
Not Provided
Principal Investigator: Rebecca Roylance, MD Barts and the London School of Medicine and Dentistry
Investigator: Elinor Sawyer, MD Cancer Research UK
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP