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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02872 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000698458 | |||
| GOG-8023 | Other Identifier | Gynecologic Oncology Group | |
| GOG-8023 | Other Identifier | CTEP | |
| R21CA135467 | U.S. NIH Grant/Contract | View source | |
| U10CA027469 | U.S. NIH Grant/Contract | View source | |
| U10CA037517 | 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 blood and tissue samples from patients with uterine cancer. Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer.
PRIMARY OBJECTIVES:
I. Determine whether synuclein-γ (SNCG) expression in primary tumor is associated with overall survival (OS) in uterine papillary serous carcinoma (UPSC) patients.
SECONDARY OBJECTIVES:
I. Determine whether SNCG expression is associated with clinical covariates (age at diagnosis, race, surgical stage, depth of myometrial invasion, presence of lymph vascular space invasion, lymph node status, location of extrauterine disease, chemotherapy, and radiation therapy) in UPSC patients.
II. Determine whether SNCG expression is associated with other biomarker expression, including TP53 (p53), HER-2, folate receptor alpha (FOLR1), estrogen receptor (ER), progesterone receptor (PR), phosphatase and tensin homolog (PTEN), phosphorylated AKT (pAKT), pERK, and p16 in primary tumor tissue.
III. Determine whether SNCG expression is associated with progression-free survival (PFS).
IV. Determine whether SNCG expression is associated with synchronous or metachronous breast cancers.
EXPLORATORY OBJECTIVES:
I. Determine whether SNCG can be detected in sera from UPSC patients. II. Determine whether serum SNCG in UPSC patients differs from that in normal healthy control women and women with endometrioid endometrial cancer.
III. Determine whether serum SNCG in UPSC patients is associated with overall survival (OS), clinical covariates (listed above), tumor expression of biomarkers (listed above), PFS, and synchronous or metachronous breast cancers.
IV. Develop prediction models with a panel of biomarkers and clinical prognostic factors for OS, PFS, and synchronous or metachronous breast cancers in UPSC patients.
OUTLINE:
Archived serum and tumor tissue samples are analyzed for synuclein-γ (SNCG) expression and other biomarker expression, including TP53 (p53), HER-2, folate receptor alpha (FOLR1), estrogen receptor (ER), progesterone receptor (PR), phosphatase and tensin homolog (PTEN), phosphorylated AKT (pAKT), pERK, and p16 by microarray analysis, IHC assays, and western blot. Results are then compared with patients' existing clinical, demographic, and pathology data, including history of breast cancer (metachronous) or breast cancer diagnosed at the same time as the endometrial cancer (synchronous).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Archived serum and tumor tissue samples are analyzed for synuclein-γ (SNCG) expression and other biomarker expression, including TP53 (p53), HER-2, folate receptor alpha (FOLR1), estrogen receptor (ER), progesterone receptor (PR), phosphatase and tensin homolog (PTEN), phosphorylated AKT (pAKT), pERK, and p16 by microarray analysis, IHC assays, and western blot. Results are then compared with patients' existing clinical, demographic, and pathology data, including history of breast cancer (metachronous) or breast cancer diagnosed at the same time as the endometrial cancer (synchronous). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Kaplan-Meier survival curves for the overall survival (OS) endpoint will be generated separately for the three SNCG expression groups and globally compared using a log-rank test. | From time of entry onto GOG-0210, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of synchronous or metachronous breast cancer | Cox proportional hazards models with dummy variable coding of the SNCG expression groups will be used to estimate hazard ratios, with tests of interaction with time and log-log plots used to evaluate the proportional hazards assumption. Sensitivity of the estimated hazard ratios to adjustment for other variables will be explored in the analyses for the Secondary Objectives. |
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Inclusion Criteria:
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Patients with uterine cancer
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Buttin | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
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| Immunohistochemistry Staining Method |
| Other |
Correlative studies |
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| Medical Chart Review | Other | Correlative studies |
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| Microarray Analysis | Genetic | Correlative studies |
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| Study of Socioeconomic and Demographic Variables | Other | Correlative studies |
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| Western Blotting | Genetic | Correlative studies |
|
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| Up to 2 years |
| Progression-free survival | Median survival times and 95% confidence intervals will be estimated from the Kaplan-Meier curves using Greenwood's formula for variance estimation. | From time of entry onto GOG-0210 to time of progression, assessed up to 2 years |
| ID | Term |
|---|---|
| D007150 | Immunohistochemistry |
| D046228 | Microarray Analysis |
| D059467 | Transcriptome |
| D020869 | Gene Expression Profiling |
| D015153 | Blotting, Western |
| ID | Term |
|---|---|
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D046208 | Microchip Analytical Procedures |
| D014158 | Transcription, Genetic |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D015870 | Gene Expression |
| D055614 | Genetic Phenomena |
| D040342 | Genetic Structures |
| D005821 | Genetic Techniques |
| D004586 | Electrophoresis |
| D002623 | Chemistry Techniques, Analytical |
| D055664 | Electrochemical Techniques |
| D015151 | Immunoblotting |
| D007118 | Immunoassay |
| D015336 | Molecular Probe Techniques |
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