Trials / Completed
CompletedNCT00897845
Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer
Molecular Profiling of E2197 FFPE Samples Using a Custom 512 Breast Cancer Gene Set on the DASL Platform: Towards the Development of Predictive Gene Sets for Risk of Recurrence in Patients With Operable Breast Cancer Treated With Adjuvant Therapy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,541 (actual)
- Sponsor
- ECOG-ACRIN Cancer Research Group · Network
- Sex
- Female
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
OBJECTIVES: Primary * To identify gene sets for risk of recurrence using molecular profiling in samples from women with lymph node-positive or high-risk lymph node-negative breast cancer on clinical trial ECOG-E2197. Secondary * To define a set of significant genes as prognostic markers of recurrence. * To compare the prognostic value of the Oncotype DX™ (ODX) 21 gene assay of clinical trial with gene sets determined in this study. * To compare the DASL™ assay of the ODX 21 genes with ODX assay results of clinical trial. * To compare the prognostic value of selected genes with gene sets determined in this study. OUTLINE: This is a multicenter study. Samples are used in molecular profiling by applying a custom panel of breast cancer-related genes to a cDNA-mediated Annealing, Selection, Extension, and Ligation (DASL™) assay, immunohistochemistry, and other studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | RNA analysis | |
| GENETIC | microarray analysis | |
| OTHER | immunohistochemistry staining method | |
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2008-06-17
- Primary completion
- 2013-12-02
- Completion
- 2013-12-02
- First posted
- 2009-05-12
- Last updated
- 2017-05-17
Source: ClinicalTrials.gov record NCT00897845. Inclusion in this directory is not an endorsement.