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CompletedNCT00918892Updated Aug 1, 2022

Assessment of Candidate Protein Expression in Breast Cancer Specimens

An observational study in Breast Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-08-01.

Sponsored by Case Comprehensive Cancer Center · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
460
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • To determine if candidate genes display differential expression between normal and cancer breast tissues.

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

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
  • estrogen receptor-negative breast cancer
  • estrogen receptor-positive breast cancer
  • progesterone receptor-negative breast cancer
  • progesterone receptor-positive breast cancer
  • triple-negative breast cancer
  • HER2-negative breast cancer
  • HER2-positive breast cancer
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 460 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • There are no exclusion criteria in this protocol
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
460 participants (actual)
Biospecimen retention
Samples with dna

Interventions

  • Geneticgene expression analysis

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

  • Otherimmunohistochemistry staining method

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

  • Otherlaboratory biomarker analysis

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

06

What researchers measure

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

    Time frame: non-applicable

07

Study locations

1 site
  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
    Cleveland, Ohio 44106-5065, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00918892
Lead sponsor
Case Comprehensive Cancer Center
Responsible party
Sponsor
First posted
Jun 11, 2009
Start date
Jan 1, 2011
Primary completion
Sep 23, 2021
Completion
Sep 23, 2021
Last update
Aug 1, 2022

Study contacts

Stefanie Avril, MD
principal investigator · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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