Glycoprotein and Glycan in Tissue and Blood Samples of Patients With Stage IB-IVA Cervical Cancer Undergoing Surgery to Remove Pelvic and Abdominal Lymph Nodes
NCT ID: NCT00460356
Last Updated: 2017-08-24
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
159 participants
OBSERVATIONAL
2007-04-02
2016-07-16
Brief Summary
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Detailed Description
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I. Determine whether the presence of a mutation in T-synthase or Cosmc and/or the presence of positive immunohistochemical expression of Tn antigen or sialyl Tn antigen in tumor specimens is associated with progression-free or overall survival in patients with stage IB2, II, III, or IVA cervical cancer undergoing pelvic and para-aortic (abdominal) lymphadenectomy.
SECONDARY OBJECTIVES:
I. Determine whether the presence of a mutation in T-synthase or Cosmc and/or the presence of positive immunohistochemical expression of Tn antigen or sialyl Tn antigen in tumor specimens is associated with lymph node metastasis or local control.
II. Identify a glycoprotein profile from a customized gene expression array analysis in tumor specimens or a glycan profile from a customized glycan array in serum that is associated with lymph node metastasis, local control, disease recurrence/progression, or survival.
III. Determine whether differences exist in T-synthase or Cosmc mutations, the immunohistochemical expression of Tn antigen or sialyl Tn antigen, and glycoprotein profiling (using customized gene expression array analysis) in matched primary tumor compared with metastatic lymph nodes that are associated with lymph node metastasis, local control, disease recurrence/progression, or survival.
IV. Identify differences in glycoprotein expression profiling and glycan profiling in tumor specimens with or without a mutation in T-synthase or Cosmc, or in tumor specimens with or without positive immunohistochemical expression of Tn antigen or sialyl Tn antigen that are associated with lymph node metastasis, local control, disease recurrence/progression, or survival.
OUTLINE:
Primary and metastatic tumor specimens are collected during lymphadenectomy and used for tissue microarray analysis, mutational analysis of T-synthase and Cosmc, immunohistochemical staining of Tn antigen and sialyl Tn antigen, and customized gene expression array analysis of 400 genes associated with glycobiology. Pre-lymphadenectomy blood is collected from patients at baseline for customized glycan array analysis of 300 carbohydrates.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Conditions
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Study Groups
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Ancillary-Correlative (glycoprotein and glycan profiling)
Primary and metastatic tumor specimens are collected during lymphadenectomy and used for tissue microarray analysis, mutational analysis of T-synthase and Cosmc, immunohistochemical staining of Tn antigen and sialyl Tn antigen, and customized gene expression array analysis of 400 genes associated with glycobiology. Pre-lymphadenectomy blood is collected from patients at baseline for customized glycan array analysis of 300 carbohydrates.
Laboratory Biomarker Analysis
Correlative studies
Lymphadenectomy
Undergo lymphadenectomy
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Lymphadenectomy
Undergo lymphadenectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have met the pre-entry requirements
* Patients with a block or 25 unstained sections of formalin-fixed and paraffin-embedded primary tumor available to satisfy the primary tumor requirement
* Patients who have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria
18 Years
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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Michael Gold
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States
Augusta University Medical Center
Augusta, Georgia, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Saint Louis University Hospital
St Louis, Missouri, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
Lake University Ireland Cancer Center
Mentor, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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NCI-2009-00592
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000540243
Identifier Type: -
Identifier Source: secondary_id
GOG-0221
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0221
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0221
Identifier Type: -
Identifier Source: org_study_id
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