This clinical trial studies 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. Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors learn how far the disease has spread.
PRIMARY OBJECTIVE: 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.
Study Type
OBSERVATIONAL
Enrollment
159
Correlative studies
Undergo lymphadenectomy
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
...and 8 more locations
Differences in 10 of the 300 carbohydrates under examination using the customized glycan array
Time frame: Up to 3 years
Differences in approximately 50 of the 400 genes on the customized glycogene expression array
Time frame: Up to 3 years
Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen
Time frame: Up to 3 years
Presence of T-synthase or Cosmc mutation
Time frame: Up to 3 years
Local control
Time frame: Up to 3 years
Lymph node metastasis
Time frame: Up to 3 years
Overall survival
Time frame: Up to 3 years
Progression-free survival (recurrence and disease progression)
Time frame: Up to 3 years
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