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: July 15, 2009

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 7, 2009

Last Updated Date

July 15, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00935233 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Analysis of acquired genetic changes within DCIS [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Genetic: DNA analysis
Genetic: polymorphism analysis
Genetic: protein analysis
Other: laboratory biomarker analysis
Other: questionnaire administration
Other: survey administration

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

6000

Completion Date

Not Provided

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00935233

Other Study ID Numbers ^ICMJE

CDR0000629681, CRUK-ICICLE, EU-20895

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Queen Mary University of London

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

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

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