NCT00949013

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. It may also help doctors predict how patients enrolled on clinical trial SWOG-9313 will respond to doxorubicin and cyclophosphamide. PURPOSE: This laboratory study is looking at tumor tissue samples from women with early-stage breast cancer enrolled on clinical trial SWOG-9313.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 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

January 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

July 29, 2009

Last Update Submit

May 23, 2014

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

  • Correlation of ALDH1 with disease-free survival and overall survival

    Retrospectively

Secondary Outcomes (1)

  • Correlation of ALDH1 with other biomarkers (TOPOII, HER2, ER, PgR)

    Retrospectively

Interventions

immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

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

Patients enrolled to S9313 consenting to banking

DISEASE CHARACTERISTICS: * Tumor samples collected from women diagnosed with early-stage breast cancer on clinical trial SWOG-9313 available PATIENT CHARACTERISTICS: * 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

Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Study Officials

  • Daniel F. Hayes, MD

    University of Michigan Rogel Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 26, 2014

Record last verified: 2014-05