Clinical trial NCT00935233: Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers
Official title: ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-07-08
Enrollment: 6000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

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

Primary outcomes:
measure: Collection of blood and/or tumor tissue
measure: Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS)
measure: Effect of these variants on tumor risk
measure: Benefit of testing for these variants
Secondary outcomes:
measure: Analysis of acquired genetic changes within DCIS
Other outcomes:
Locations:
city: Barnstaple
country: United Kingdom
facility: North Devon District Hospital
state: England
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Cumberland Infirmary
state: England
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
state: England
city: Dartford Kent
country: United Kingdom
facility: Dartford & Gravesham NHS Trust, Joyce Green Hospital
state: England
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
state: England
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: England
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
state: England
city: London
country: United Kingdom
facility: Barts and the London School of Medicine
state: England
city: London
country: United Kingdom
facility: Helen Rollason Cancer Care Centre at North Middlesex Hospital
state: England
city: London
country: United Kingdom
facility: Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
state: England
city: London
country: United Kingdom
facility: King's College Hospital
state: England
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
city: Orpington, Kent
country: United Kingdom
facility: Princess Royal University Hospital
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
state: England
city: Dumfries
country: United Kingdom
facility: Dumfries & Galloway Royal Infirmary
state: Scotland
city: Aberystwyth
country: United Kingdom
facility: Bronglais District General Hospital
state: Wales
Study officials:
affiliation: Barts and the London School of Medicine and Dentistry
name: Rebecca Roylance, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Research UK
name: Elinor Sawyer, MD
References: