Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer
Recruitment status was Not yet recruiting
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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 |
- Association of SNGC expression with overall survival [ Designated as safety issue: No ]
- 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) |
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 |
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
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:
|
Cystadenocarcinoma, Serous Cystadenocarcinoma Endometrial Neoplasms Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Diseases Genital Diseases, Female Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous |
ClinicalTrials.gov processed this record on May 16, 2013