Clinical Trial: Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.

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.



Original Primary Outcome: Association of SNGC expression with overall survival

Current Secondary Outcome:

  • Presence of synchronous or metachronous breast cancer [ Time Frame: Up to 2 years ]
    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.
  • Progression-free survival [ Time Frame: From time of entry onto GOG-0210 to time of progression, assessed up to 2 years ]
    Median survival times and 95% confidence intervals will be estimated from the Kaplan-Meier curves using Greenwood's formula for variance estimation.


Original Secondary Outcome:

  • Association of SNGC expression with progression-free survival
  • Association of SNGC expression with clinical covariates
  • Association of SNCG expression 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, ...
  • Association between SNCG expression and synchronous or metachronous breast cancers


Information By: Gynecologic Oncology Group

Dates:
Date Received: April 28, 2011
Date Started: January 2100
Date Completion:
Last Updated: May 27, 2015
Last Verified: May 2015