NCT01344837

Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 360 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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 description

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).

Conditions

• Endometrial Serous Adenocarcinoma
• Stage I Uterine Corpus Cancer
• Stage II Uterine Corpus Cancer
• Stage III Uterine Corpus Cancer
• Stage IV Uterine Corpus Cancer

Interventions

Type	Name	Description
OTHER	Diagnostic Laboratory Biomarker Analysis	Correlative studies
OTHER	Immunohistochemistry Staining Method	Correlative studies
OTHER	Medical Chart Review	Correlative studies
GENETIC	Microarray Analysis	Correlative studies
OTHER	Study of Socioeconomic and Demographic Variables	Correlative studies
GENETIC	Western Blotting	Correlative studies

Timeline

• Start date: 2010-01-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2011-04-29
• Last updated: 2024-08-14

Locations

1 site across 1 country: United States