Trials / Completed
CompletedNCT01164735
Biomarkers in Tumor Tissue Samples From Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Topoisomerase 2-Alpha (TOPO2A) Genomic Alterations and Immunohistochemical Expression as Well as Chromosome 17 Polysomy in Advanced or Recurrent Endometrial Carcinoma Treated With Anthracycline-Based Therapy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 169 (actual)
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This research study is studying biomarkers in tissue samples from patients with stage III, stage IV, or recurrent endometrial cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
Detailed description
PRIMARY OBJECTIVES: I. To determine the frequency of topoisomerase 2-alpha (TOPO2A) gene copy number alterations (including deletions, gains, and amplification), immunohistochemical expression, and chromosome 17 polysomy in tumor tissue samples from patients with advanced or recurrent endometrial carcinoma treated with anthracycline-based therapy on Gynecologic Oncology Group (GOG)-0177. II. To assess the relationship between TOPO2A gene copy number alterations, TOPO2A protein expression, chromosome 17 polysomy, and human epidermal growth factor receptor 2 (HER2) status in tumor tissue samples from these patients. III. To assess the association between TOPO2A status (TOPO2A gene copy number alterations and TOPO2A protein expression), or chromosome 17 polysomy and clinical covariates (e.g., age, race/ethnicity, cell type, histologic grade, disease stage, regimen type). IV. To assess the association between TOPO2A status or chromosome 17 polysomy with measures of clinical outcome including response, progression-free survival, and overall survival of patients treated with this regimen. V. To evaluate the potential identification of cut points for TOPO2A protein expression with potential prognostic value in patients treated with this regimen. OUTLINE: Archived tumor tissue samples are analyzed for topoisomerase 2-alpha gene alteration and expression and chromosome 17 polysomy by fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC). Clinical information associated with each endometrial carcinoma sample (e.g., age, race/ethnicity, cell type, histologic grade, disease stage, and regimen type) is also collected.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2018-01-01
- Completion
- 2018-01-01
- First posted
- 2010-07-19
- Last updated
- 2024-08-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01164735. Inclusion in this directory is not an endorsement.