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Gene Expression in Tumor Tissue From Women Undergoing Surgery for Breast Cancer or Core Biopsy of the Breast

Pilot Study for Analysis of Tumor Gene Expression by DNA Microarray Analysis in Patients Undergoing Breast Cancer Surgery or Core Biopsy Sampling

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00898937
Enrollment
55
Registered
2009-05-12
Start date
1999-09-30
Completion date
2017-07-31
Last updated
2018-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer

Brief summary

RATIONALE: Studying samples of breast tissue in the laboratory may help doctors learn more about the genes and proteins found in breast tissue. PURPOSE: This phase I trial is studying genes and proteins in breast tissue from women undergoing surgery for breast cancer or core biopsy of the breast.

Detailed description

OBJECTIVES: * Assess tumor gene expression information from women undergoing surgery for breast cancer or core biopsy sampling of the breast. OUTLINE: This is a pilot study. Tumor tissue is collected and analyzed for tumor gene expression by DNA microarray analysis for research studies. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Interventions

GENETICmicroarray analysis

tumor specimen will be assessed by microarray analysis

PROCEDUREbreast biopsy

A breast biopsy will be done to obtain a tumor specimen

Sponsors

Georgetown University
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Undergoing surgery for breast cancer OR core biopsy sampling of the breast PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

MeasureTime frameDescription
Tumor Gene Expression as Assessed by RNA Microarray Analysis1 dayConcentration of RNA recovered from breast needle biopsies

Countries

United States

Participant flow

Participants by arm

ArmCount
Snap-frozen
Method of RNA recovery: Snap-frozen
25
RNALater
Method of RNA recovery: RNALater
21
Unknown
Method of RNA recovery: unknown
9
Total55

Baseline characteristics

CharacteristicSnap-frozenRNALaterUnknownTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
25 Participants21 Participants9 Participants55 Participants
Race and Ethnicity Not Collected———0 Participants
Sex: Female, Male
Female
25 Participants21 Participants9 Participants55 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

Tumor Gene Expression as Assessed by RNA Microarray Analysis

Concentration of RNA recovered from breast needle biopsies

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Snap-frozenTumor Gene Expression as Assessed by RNA Microarray Analysis2.04 microgramsStandard Error 0.51
RNALaterTumor Gene Expression as Assessed by RNA Microarray Analysis3.49 microgramsStandard Error 0.78
UnknownTumor Gene Expression as Assessed by RNA Microarray Analysis3.63 microgramsStandard Error 0.48

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026