Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer

Completed

• Conditions: Endometrial Serous Adenocarcinoma; Stage II Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer; Stage I Uterine Corpus Cancer; Stage III Uterine Corpus Cancer
• Interventions: Other: Diagnostic Laboratory Biomarker Analysis; Other: Immunohistochemistry Staining Method; Other: Medical Chart Review; Genetic: Microarray Analysis; Other: Study of Socioeconomic and Demographic Variables; Genetic: Western Blotting

• Registration Number: NCT01344837
• Lead Sponsor: Gynecologic Oncology Group

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 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).

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 360

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Diagnostic Laboratory Biomarker Analysis	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).
Observational	Medical Chart Review	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).
Observational	Microarray Analysis	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).
Observational	Study of Socioeconomic and Demographic Variables	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).
Observational	Western Blotting	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).
Observational	Immunohistochemistry Staining Method	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).

Primary Outcome Measures

Name	Time	Method
Overall survival	From time of entry onto GOG-0210, assessed up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Presence of synchronous or metachronous breast cancer	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	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.

Trial Locations

Locations (1)

Gynecologic Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States