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


N/A
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Collection of blood and/or tumor tissue

Safety Issue:

No

Principal Investigator

Rebecca Roylance, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barts and the London School of Medicine and Dentistry

Authority:

Unspecified

Study ID:

CDR0000629681

NCT ID:

NCT00935233

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating

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