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The Role of Synuclein-gamma (SNCG) in the Carcinogenesis of Uterine Papillary Serous Carcinoma


N/A
N/A
N/A
Not Enrolling
Female
Endometrial Cancer

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Trial Information

The Role of Synuclein-gamma (SNCG) in the Carcinogenesis of Uterine Papillary Serous Carcinoma


OBJECTIVES:

Primary

- Determine whether synuclein-γ (SNCG) expression in primary tumor is associated with
overall survival (OS) in uterine papillary serous carcinoma (UPSC) patients.

Secondary

- 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.

- 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.

- Determine whether SNCG expression is associated with progression-free survival (PFS).

- Determine whether SNCG expression is associated with synchronous or metachronous breast
cancers.

- Determine whether SNCG can be detected in sera from UPSC patients. (Exploratory)

- Determine whether serum SNCG in UPSC patients differs from that in normal healthy
control women and women with endometrioid endometrial cancer. (Exploratory)

- 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. (Exploratory)

- Develop prediction models with a panel of biomarkers and clinical prognostic factors
for OS, PFS, and synchronous or metachronous breast cancers in UPSC patients.
(Exploratory)

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


DISEASE CHARACTERISTICS:

- Must meet 1 of the following 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:

- Histologically confirmed UPSC of any stage

- 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:

- Histologically confirmed endometrioid endometrial carcinoma with a similar
stage, age, and race/ethnicity distribution as the UPSC patients

- 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:

- Do not have a cancer or a history of cancer and have a similar age and
race/ethnicity distribution as the UPSC patients

- Satisfactory serum available for testing

PATIENT CHARACTERISTICS:

- Consented to future research (patients and healthy controls)

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Association of SNGC expression with overall survival

Safety Issue:

No

Principal Investigator

Barbara M. Buttin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

Unspecified

Study ID:

CDR0000698458

NCT ID:

NCT01344837

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • endometrial papillary serous carcinoma
  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Endometrial Neoplasms
  • Cystadenocarcinoma, Serous
  • Adenoma

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