NCT00898937

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 13, 2018

Completed
Last Updated

April 13, 2018

Status Verified

February 1, 2018

Enrollment Period

15.3 years

First QC Date

May 9, 2009

Results QC Date

March 5, 2018

Last Update Submit

April 12, 2018

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor Gene Expression as Assessed by RNA Microarray Analysis

    Concentration of RNA recovered from breast needle biopsies

    1 day

Interventions

microarray analysisGENETIC

tumor specimen will be assessed by microarray analysis

breast biopsyPROCEDURE

A breast biopsy will be done to obtain a tumor specimen

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any woman undergoing a breast biopsy or breast surgery

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

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

Sponsors & Collaborators

Study Sites (1)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Microarray Analysis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative Techniques

Results Point of Contact

Title
Claudine Isaacs
Organization
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
isaacsc@georgetown.edu
202-444-3677

Study Officials

  • Claudine Isaacs, MD

    Lombardi Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

September 1, 1999

Primary Completion

December 1, 2014

Study Completion

July 1, 2017

Last Updated

April 13, 2018

Results First Posted

April 13, 2018

Record last verified: 2018-02

Locations

US(1)