NCT00041353

Brief Summary

RATIONALE: Examining biomarkers in fine-needle aspiration specimens from women at risk for breast cancer may improve the ability to detect breast cancer cells early and plan effective treatment. PURPOSE: Screening trial to compare specific biomarkers based on fine-needle aspiration specimens from women at increased or normal risk of breast cancer.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2002

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 26, 2003

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

First QC Date

July 8, 2002

Last Update Submit

July 10, 2013

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situlobular breast carcinoma in situ

Interventions

cytology specimen collection procedureOTHER
comparison of screening methodsPROCEDURE
study of high risk factorsPROCEDURE

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Increased risk of breast cancer as determined by 1 or more first-degree relatives (mother, sister, or daughter) with a history of breast cancer OR a personal history of atypical hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ of the breast OR * No increased risk of breast cancer as determined by a lack of the above conditions * Scheduled to undergo elective breast surgery for removal of a mammographic lesion or palpable breast lump * No prior bilateral mastectomy or bilateral breast irradiation * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 30 and over Sex: * Female Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No active invasive malignancy in any site except basal cell or squamous cell skin cancer * No significant medical or psychiatric problems that would preclude study * No evidence of excessive use of narcotics or drug dependency PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingBreast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • Michael H. Torosian, MD

    Fox Chase Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SCREENING
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2002

First Posted

May 26, 2003

Primary Completion

September 1, 2002

Study Completion

September 1, 2002

Last Updated

July 11, 2013

Record last verified: 2013-07