NCT00897845

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor samples from women who have undergone chemotherapy for breast cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,541

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Status
completed

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

June 17, 2008

Completed
11 months 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
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2013

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

5.5 years

First QC Date

May 9, 2009

Last Update Submit

May 16, 2017

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerstage IIIB breast cancer

Outcome Measures

Primary Outcomes (1)

  • Correlation of results with Outcome

    1 month

Interventions

RNA analysisGENETIC
microarray analysisGENETIC
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patients enrolled on E2197

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer tumor samples collected on clinical trial ECOG-E2197 * Histologically lymph node-positive (N1-3) OR high-risk lymph node-negative disease * Hormone receptor-positive or negative disease (status known) * HER2 status known PATIENT CHARACTERISTICS: * Menopausal status not specified PRIOR CONCURRENT THERAPY: * 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 Neoplasms

Interventions

Microarray AnalysisImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Brian Leyland-Jones, MD

    Emory University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

June 17, 2008

Primary Completion

December 2, 2013

Study Completion

December 2, 2013

Last Updated

May 17, 2017

Record last verified: 2017-05