NCT00918892

Brief Summary

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

10.7 years

First QC Date

June 9, 2009

Last Update Submit

July 29, 2022

Conditions

Keywords

breast cancerestrogen receptor-negative breast cancerestrogen receptor-positive breast cancerprogesterone receptor-negative breast cancerprogesterone receptor-positive breast cancertriple-negative breast cancerHER2-negative breast cancerHER2-positive breast cancer

Outcome Measures

Primary Outcomes (1)

  • Differential expression of candidate genes between normal and cancer breast tissues

    Approximately 5 slides of each tumor will be collected to provide sufficient samples for replicate staining, if necessary, as well as a staining for a positive control

    non-applicable

Interventions

Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

You may qualify if:

  • DISEASE CHARACTERISTICS:
  • Diagnosis of breast cancer
  • Tissue samples available
  • Samples are selected based on presence or absence of tumor receptors, (i.e.; estrogen, progesterone, and HER2 receptors) and grouped into following 4 categories:
  • Estrogen receptor (ER)-positive/progesterone receptor (PR)-positive/HER2-negative
  • ER-positive/PR-positive/ HER2-positive by FISH
  • ER-negative/PR-negative/HER2-positive
  • ER-negative/PR-negative/HER2-negative(triple negative or basal-type cancers)
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • PRIOR CONCURRENT THERAPY:
  • Not specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

Gene Expression ProfilingImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Stefanie Avril, MD

    University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 11, 2009

Study Start

January 1, 2011

Primary Completion

September 23, 2021

Study Completion

September 23, 2021

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations