Endometrial Serous Adenocarcinoma Clinical Trial
Official title:
The Role of Synuclein-gamma (SNCG) in the Carcinogenesis of Uterine Papillary Serous Carcinoma
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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Observational Model: Cohort, Time Perspective: Retrospective
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