Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer
NCT ID: NCT01344837
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
360 participants
OBSERVATIONAL
2010-01-31
2018-01-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Observational
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).
Diagnostic Laboratory Biomarker Analysis
Correlative studies
Immunohistochemistry Staining Method
Correlative studies
Medical Chart Review
Correlative studies
Microarray Analysis
Correlative studies
Study of Socioeconomic and Demographic Variables
Correlative studies
Western Blotting
Correlative studies
Interventions
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Diagnostic Laboratory Biomarker Analysis
Correlative studies
Immunohistochemistry Staining Method
Correlative studies
Medical Chart Review
Correlative studies
Microarray Analysis
Correlative studies
Study of Socioeconomic and Demographic Variables
Correlative studies
Western Blotting
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Barbara Buttin
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NCI-2011-02872
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000698458
Identifier Type: -
Identifier Source: secondary_id
GOG-8023
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-8023
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-8023
Identifier Type: -
Identifier Source: org_study_id
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