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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00935233
• Other study ID #: CRUK-ICICLE
• Secondary ID: CDR0000629681EU-
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2009
• Last updated: August 9, 2013
• Start date: July 2008

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ

Intervention

Genetic:
• DNA analysis

• polymorphism analysis

• protein analysis

Other:
• laboratory biomarker analysis

• questionnaire administration

• survey administration

Locations

Country	Name	City	State
United Kingdom	Bronglais District General Hospital	Aberystwyth	Wales
United Kingdom	North Devon District Hospital	Barnstaple	England
United Kingdom	Basildon University Hospital	Basildon	England
United Kingdom	Cumberland Infirmary	Cambridge	England
United Kingdom	Colchester General Hospital	Colchester	England
United Kingdom	Dartford & Gravesham NHS Trust, Joyce Green Hospital	Dartford Kent	England
United Kingdom	Dorset County Hospital	Dorchester	England
United Kingdom	Dumfries & Galloway Royal Infirmary	Dumfries	Scotland
United Kingdom	Northwick Park Hospital	Harrow	England
United Kingdom	West Middlesex University Hospital	Isleworth	England
United Kingdom	Barts and the London School of Medicine	London	England
United Kingdom	Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals	London	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Helen Rollason Cancer Care Centre at North Middlesex Hospital	London	England
United Kingdom	King's College Hospital	London	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Princess Royal University Hospital	Orpington, Kent	England
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of blood and/or tumor tissue			No
Primary	Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS)			No
Primary	Effect of these variants on tumor risk			No
Primary	Benefit of testing for these variants			No
Secondary	Analysis of acquired genetic changes within DCIS			No