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Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer

Trial Status: Approved

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.

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

Pennsylvania

Philadelphia
Gynecologic Oncology Group
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Barbara Malalai Buttin
Phone: 312-472-4684

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).

Trial Phase Phase NA

Trial Type Ancillary-correlative

Lead Organization
Gynecologic Oncology Group

Principal Investigator
Barbara Malalai Buttin

  • Primary ID GOG-8023
  • Secondary IDs NCI-2011-02872, CDR0000698458
  • Clinicaltrials.gov ID NCT01344837