Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01344837
First received: April 28, 2011
Last updated: May 3, 2011
Last verified: April 2011
  Purpose

RATIONALE: 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.

PURPOSE: This research study is studying biomarkers in blood and tissue samples from patients with uterine cancer.


Condition Intervention
Endometrial Cancer
Genetic: microarray analysis
Genetic: western blotting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: medical chart review
Other: study of socioeconomic and demographic variables

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Association of SNGC expression with overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of SNGC expression with progression-free survival [ Designated as safety issue: No ]
  • Association of SNGC expression with clinical covariates [ Designated as safety issue: No ]
  • 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, ... [ Designated as safety issue: No ]
  • Association between SNCG expression and synchronous or metachronous breast cancers [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: April 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine whether synuclein-γ (SNCG) expression in primary tumor is associated with overall survival (OS) in uterine papillary serous carcinoma (UPSC) patients.

Secondary

  • 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.
  • 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.
  • Determine whether SNCG expression is associated with progression-free survival (PFS).
  • Determine whether SNCG expression is associated with synchronous or metachronous breast cancers.
  • Determine whether SNCG can be detected in sera from UPSC patients. (Exploratory)
  • Determine whether serum SNCG in UPSC patients differs from that in normal healthy control women and women with endometrioid endometrial cancer. (Exploratory)
  • 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. (Exploratory)
  • Develop prediction models with a panel of biomarkers and clinical prognostic factors for OS, PFS, and synchronous or metachronous breast cancers in UPSC patients. (Exploratory)

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).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Must meet 1 of the following 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:

      • Histologically confirmed UPSC of any stage
      • 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:

      • Histologically confirmed endometrioid endometrial carcinoma with a similar stage, age, and race/ethnicity distribution as the UPSC patients
      • 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:

      • Do not have a cancer or a history of cancer and have a similar age and race/ethnicity distribution as the UPSC patients
      • Satisfactory serum available for testing

PATIENT CHARACTERISTICS:

  • Consented to future research (patients and healthy controls)

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344837

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Barbara M. Buttin, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01344837     History of Changes
Other Study ID Numbers: CDR0000698458, GOG-8023
Study First Received: April 28, 2011
Last Updated: May 3, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
endometrial papillary serous carcinoma
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Cystadenocarcinoma, Serous
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Cystadenocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous

ClinicalTrials.gov processed this record on August 27, 2014