Biomarkers in Blood and Tissue Samples From Patients With Uterine 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).

Inclusion Criteria:

- Women with uterine papillary serous carcinoma (UPSC) who were eligible for GOG-0210
protocol, a molecular staging study in endometrial cancer, or GOG-0136, a general
specimen banking study for gynecologic cancer, have consented to future research,
have histologically-confirmed UPSC of any stage, and have satisfactory formalin-fixed
and paraffin-embedded primary tumor with or without a satisfactory pre-operative
serum specimen available for testing

- Women with endometrioid endometrial cancer who were eligible for GOG-0210 or
GOG-0136, have consented to future research, have histologically-confirmed
endometrioid endometrial carcinoma with a similar stage, age and race/ethnicity
distribution as the UPSC patients, have satisfactory formalin-fixed and
paraffin-embedded primary tumor and/or pre-operative serum specimen available for
testing

- Normal healthy control women who participated in the Biopathology protocol for
banking sera from normal healthy control women, have consented to future research, do
not have a cancer or a history of cancer and have a similar age and race/ethnicity
distribution as the UPSC patients and have satisfactory serum available for testing