Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer

Gynecologic Oncology Group (GOG)

Status

Completed

Conditions

Stage I Uterine Corpus Cancer

Stage IV Uterine Corpus Cancer

Endometrial Serous Adenocarcinoma

Stage II Uterine Corpus Cancer

Stage III Uterine Corpus Cancer

Treatments

Genetic: Western Blotting

Other: Medical Chart Review

Genetic: Microarray Analysis

Other: Study of Socioeconomic and Demographic Variables

Other: Immunohistochemistry Staining Method

Other: Diagnostic Laboratory Biomarker Analysis

Study type

Observational

Funder types

NETWORK

NIH

Identifiers

NCT01344837

U10CA027469 (U.S. NIH Grant/Contract)

R21CA135467 (U.S. NIH Grant/Contract)

NCI-2011-02872 (Registry Identifier)

U10CA037517 (U.S. NIH Grant/Contract)

CDR0000698458

GOG-8023 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

360 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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