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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02245 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000681556 | |||
| GOG-8013 | |||
| GOG-8013 | Other Identifier | Gynecologic Oncology Group | |
| GOG-8013 | Other Identifier | CTEP | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Correlative studies | Archived tumor tissue samples are analyzed for topoisomerase 2-alpha gene alteration and expression and chromosome 17 polysomy by FISH and 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The Kaplan-Meier method will be used to estimate and plot the unadjusted survival and progression-free survival time distributions by TOPO2A expression and amplification status. | From enrollment on GOG-0177 to death (regardless of cause) or to the date of last contact for women who were alive, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response (complete or partial response) | Logistic regression modeling will be used to explore the relationship between clinical response to treatment and both TOPO2A expression and amplification. | Up to 5 years |
| Progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatyana Grushko | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34224438 | Derived | Grushko TA, Filiaci VL, Montag AG, Apushkin M, Gomez MJ, Monovich L, Ramirez NC, Schwab C, Kesterson JP, Seward SM, Method MW, Olopade OI, Fleming GF, Birrer MJ. Effects of Slide Storage on Detection of Molecular Markers by IHC and FISH in Endometrial Cancer Tissues From a Clinical Trial: An NRG Oncology/GOG Pilot Study. Appl Immunohistochem Mol Morphol. 2022 Jan 1;30(1):27-35. doi: 10.1097/PAI.0000000000000949. |
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The Kaplan-Meier method will be used to estimate and plot the unadjusted survival and progression-free survival time distributions by TOPO2A expression and amplification status.
| From enrollment on GOG-0177 to disease progression or death, or to the date of last contact for women who were still alive with no evidence of disease progression, assessed up to 5 years |